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Counter, Differential Cell

FDA product code GKZ · 375 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.5220
Review panel: HE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-02-28 – 2026-09-14

GKZ 2003-05-21

TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)

Applicant Beckman Coulter, Inc.

K number K030828

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GKZ 2003-05-12

CELL-DYN 1800 SYSTEM

Applicant Abbott Laboratories

K number K030513

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GKZ 2003-04-21

COULTER LH 750 BODY FLUIDS APPLICATION

Applicant Beckman Coulter, Inc.

K number K030606

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GKZ 2003-04-17

COULTER ACT 5DIFF AUTOLOADER (AL)

Applicant Beckman Coulter, Inc.

K number K030291

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GKZ 2003-04-08

MICROS 60

Applicant Abx Diagnostics

K number K030799

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GKZ 2003-03-04

CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A

Applicant Beckman Coulter, Inc.

K number K030408

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GKZ 2003-01-31

MODIFICATION TO PENTRA 60 AND PENTRA 60C+

Applicant Abx Diagnostics

K number K030144

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GKZ 2003-01-03

PENTRA 80

Applicant Abx Diagnostics

K number K024002

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GKZ 2002-10-15

ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

Applicant Bayer Diagnostics Corp.

K number K022668

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GKZ 2002-09-11

IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ

Applicant Iq Corp.

K number K022528

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GKZ 2002-07-29

PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120

Applicant Abx Diagnostics

K number K022200

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GKZ 2002-07-29

MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

Applicant Beckman Coulter, Inc.

K number K022161

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GKZ 2002-06-25

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

Applicant Sysmex Corporation of America

K number K021241

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GKZ 2002-04-12

HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY

Applicant Sysmex Corporation of America

K number K020496

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GKZ 2001-09-28

CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE

Applicant Abbott Laboratories

K number K012934

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GKZ 2001-09-21

ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION

Applicant Bayer Diagnostics Corp.

K number K012904

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GKZ 2001-07-09

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

Applicant Beckman Coulter, Inc.

K number K011342

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GKZ 2001-06-06

CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY

Applicant Abbott Laboratories

K number K010953

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GKZ 2001-04-13

COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

Applicant Beckman Coulter, Inc.

K number K010765

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GKZ 2001-02-05

ADVIA 120 HEMATOLOGY

Applicant Bayer Corp.

K number K003796

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GKZ 2000-12-26

ABX PENTRA 60C+ HEMATOLOGY ANALYZER

Applicant Abx Diagnostics

K number K003677

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GKZ 2000-10-26

ABX MICROS CRP

Applicant Abx Diagnostics

K number K002646

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GKZ 2000-05-18

STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

Applicant Bd Biosciences

K number K000611

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GKZ 2000-05-05

CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE

Applicant Bd Biosciences

K number K000897

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GKZ 2000-04-20

COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES

Applicant Coulter Corp.

K number K993356

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GKZ 1999-11-09

SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER

Applicant Sysmex Corp.

K number K992875

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GKZ 1999-10-15

ABX PENTRA 60 HEMATOLOGY ANALYZER

Applicant Abx Diagnostics

K number K992511

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GKZ 1999-09-24

MODIFICATION OF: CELL-DYN 1200 SYSTEM

Applicant Abbott Laboratories

K number K992444

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GKZ 1999-09-23

QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K992849

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GKZ 1999-08-11

ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER

Applicant Abx Diagnostics

K number K991839

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GKZ 1999-07-09

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION

Applicant Abbott Laboratories

K number K991605

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GKZ 1999-07-01

EXCELL 22

Applicant Mwi, Inc.

K number K991539

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GKZ 1999-06-23

CELL-DYN 1200 SYSTEM

Applicant Abbott Laboratories

K number K991142

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GKZ 1999-06-21

MOUSE IGG1 NEGATIVE CONTROLS

Applicant Dako Corp.

K number K991454

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GKZ 1999-06-21

DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1

Applicant Dako Corp.

K number K991402

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GKZ 1999-04-26

RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS

Applicant Coulter Corp.

K number K990327

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GKZ 1999-04-13

TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA

Applicant Coulter Corp.

K number K990172

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GKZ 1999-04-01

COULTER AC T DIFF 2 ANALYZER

Applicant Coulter Corp.

K number K990352

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GKZ 1999-03-31

VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER

Applicant Abx Diagnostics

K number K990311

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GKZ 1998-11-09

CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1

Applicant Coulter Corp.

K number K982167

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GKZ 1998-11-05

CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1

Applicant Coulter Corp.

K number K982166

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GKZ 1998-11-03

MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

Applicant Cdc Technologies, Inc.

K number K983562

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GKZ 1998-09-24

CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL

Applicant Coulter Corp.

K number K982172

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GKZ 1998-09-22

BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K982802

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GKZ 1998-08-21

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800

Applicant Cdc Technologies, Inc.

K number K981568

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GKZ 1998-07-22

DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37

Applicant Dako Corp.

K number K980635

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GKZ 1998-07-20

STATUSFLOW

Applicant R&D Systems, Inc.

K number K982231

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GKZ 1998-06-29

ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY

Applicant Abbott Laboratories

K number K981342

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GKZ 1998-05-22

MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION

Applicant Becton Dickinson Immunocytometry Systems

K number K980858

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GKZ 1998-04-24

ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS

Applicant Abbott Laboratories

K number K980614

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GKZ 1998-03-11

MULTITEST CD3/CD8/CD45/CD4

Applicant Becton Dickinson Immunocytometry Systems

K number K974360

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GKZ 1998-02-17

FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET

Applicant Becton Dickinson Immunocytometry Systems

K number K973483

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GKZ 1997-12-01

TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES

Applicant Becton Dickinson Immunocytometry Systems

K number K971205

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GKZ 1997-11-25

TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

Applicant Becton Dickinson Immunocytometry Systems

K number K971110

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GKZ 1997-11-21

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

Applicant Becton Dickinson Immunocytometry Systems

K number K970326

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GKZ 1997-11-21

TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES

Applicant Becton Dickinson Immunocytometry Systems

K number K965053

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GKZ 1997-10-29

COULTER AC.T DIFF ANALYZER

Applicant Coulter Corp.

K number K973634

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GKZ 1997-10-22

TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES

Applicant Becton Dickinson Immunocytometry Systems

K number K970742

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GKZ 1997-09-16

ABBOTT CELL-DYN 3200 SYSTEM

Applicant Abbott Laboratories

K number K972354

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GKZ 1997-08-26

SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER

Applicant Sysmex Corp.

K number K971736

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GKZ 1997-08-26

TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS

Applicant Becton Dickinson Immunocytometry Systems

K number K970836

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GKZ 1997-08-12

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)

Applicant Abbott Laboratories

K number K971152

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GKZ 1997-07-14

ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE

Applicant Ortho Diagnostic Systems, Inc.

K number K951459

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GKZ 1997-06-24

MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE

Applicant Dako Corp.

K number K964974

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GKZ 1997-05-14

CALTAG CAL-LYSE

Applicant Caltag Laboratories, Inc.

K number K965232

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GKZ 1997-03-06

COULTER AC.T SERIES ANALYZER

Applicant Coulter Corp.

K number K964988

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GKZ 1997-03-06

SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX

Applicant Biochem Immunosystems (U.S.), Inc.

K number K960072

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GKZ 1997-03-06

ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K951632

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GKZ 1997-01-22

ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE

Applicant Ortho Diagnostic Systems, Inc.

K number K964754

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GKZ 1997-01-22

TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5

Applicant Coulter Corp.

K number K963263

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GKZ 1997-01-17

CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

Applicant Caltag Laboratories, Inc.

K number K964856

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GKZ 1997-01-06

CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL

Applicant Coulter Corp.

K number K962768

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GKZ 1997-01-06

CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL

Applicant Coulter Corp.

K number K962305

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GKZ 1996-12-23

CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1

Applicant Coulter Corp.

K number K964618

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GKZ 1996-12-12

MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS

Applicant Becton Dickinson Immunocytometry Systems

K number K963963

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GKZ 1996-11-25

CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY

Applicant Caltag Laboratories, Inc.

K number K963954

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GKZ 1996-11-04

VEGA HEMATOLOGY ANALYZER

Applicant Abx, Inc.

K number K962633

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GKZ 1996-10-18

ABBOTT CELL-DYN 4000 SYSTEM

Applicant Abbott Diagnostics

K number K961439

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GKZ 1996-10-08

CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)

Applicant Abbott Laboratories

K number K955715

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GKZ 1996-08-23

RETICULOCYTE METHOD, RBC INDICES

Applicant Bayer Corp.

K number K954594

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GKZ 1996-07-22

COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS

Applicant Coulter Corp.

K number K961278

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GKZ 1996-07-16

MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE

Applicant Dako Corp.

K number K961701

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GKZ 1996-07-01

R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)

Applicant R&D Systems, Inc.

K number K961610

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GKZ 1996-06-14

MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE

Applicant Dako Corp.

K number K961435

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GKZ 1996-06-14

MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE

Applicant Dako Corp.

K number K960531

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GKZ 1996-06-07

FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS

Applicant Becton Dickinson Monoclonal Center

K number K961623

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GKZ 1996-06-05

MEDICOUNT DEKA HEMATOLOGY ANALYZER

Applicant Cea America Corp.

K number K942525

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GKZ 1996-05-20

CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)

Applicant Abbott Laboratories

K number K955673

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GKZ 1996-05-17

MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE

Applicant Dako Corp.

K number K960887

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GKZ 1996-05-17

QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K960827

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GKZ 1996-05-13

WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER

Applicant Intl. Remote Imaging Systems

K number K953116

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GKZ 1996-05-13

ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K951100

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GKZ 1996-05-13

ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K950625

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GKZ 1996-05-13

ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K950568

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GKZ 1996-05-10

ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K950482

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GKZ 1996-05-09

ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K935720

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GKZ 1996-05-02

ABBOTT CELL-DYN 3500R SYSTEM

Applicant Sequoia Turner Corp.

K number K960427

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GKZ 1996-04-30

ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K954570

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GKZ 1996-03-28

MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE

Applicant Dako Corp.

K number K955909

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GKZ 1996-03-22

HEMATIL 18 (H-18)

Applicant Texas Intl. Laboratories, Inc.

K number K953643

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