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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 1996-03-11

SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS

Applicant Serono Diagnostics, Inc.

K number K953598

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GKZ 1996-02-29

FLOW-COUNT COULTER FLUOROSPHERES

Applicant Coulter Corp.

K number K954688

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GKZ 1996-02-20

TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP

Applicant Becton Dickinson Immunocytometry Systems

K number K950342

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GKZ 1996-02-20

TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP

Applicant Becton Dickinson Immunocytometry Systems

K number K946055

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GKZ 1996-02-05

QBC ACCUREAD SYSTEM

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K955504

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GKZ 1996-01-26

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/

Applicant Dako Corp.

K number K945212

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GKZ 1995-12-21

CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION

Applicant Caltag Laboratories, Inc.

K number K951073

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GKZ 1995-12-21

CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION

Applicant Caltag Laboratories, Inc.

K number K950918

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GKZ 1995-12-21

CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

Applicant Caltag Laboratories, Inc.

K number K950917

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GKZ 1995-12-21

CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION

Applicant Caltag Laboratories, Inc.

K number K950916

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GKZ 1995-12-20

CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

Applicant Caltag Laboratories, Inc.

K number K950919

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GKZ 1995-12-19

IMAGN(TM) 2000 SYSTEM

Applicant Buckman Co., Inc.

K number K945756

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GKZ 1995-11-20

FACS LOADER SYSTEM

Applicant Becton Dickinson Immunocytometry Systems

K number K953302

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GKZ 1995-11-14

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT

Applicant Intracel Corp.

K number K933878

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GKZ 1995-11-03

OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL

Applicant Immunotech Corp.

K number K954188

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GKZ 1995-10-20

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

Applicant Immunotech, Inc.

K number K946335

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GKZ 1995-10-19

CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER

Applicant Abbott Laboratories

K number K951496

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GKZ 1995-10-19

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT

Applicant Buckman Co., Inc.

K number K940003

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GKZ 1995-10-13

ROCHE COBAS MICROS HEMATOLOGY ANALYZER

Applicant Roche Diagnostic Systems, Inc.

K number K953448

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GKZ 1995-10-05

QBC ACCUTUBE

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K953340

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GKZ 1995-09-25

QBC ACCUTUBE

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K945205

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GKZ 1995-09-12

DATACELL 18MS

Applicant Danam Electronics

K number K945678

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GKZ 1995-09-08

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL

Applicant Immunotech, Inc.

K number K953498

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GKZ 1995-08-25

CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT

Applicant Coulter Corp.

K number K950742

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GKZ 1995-08-22

TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP

Applicant Becton Dickinson Immunocytometry Systems

K number K950057

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GKZ 1995-08-14

OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES

Applicant Immunotech Corp.

K number K952789

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GKZ 1995-07-20

COULTER MH025A

Applicant Coulter Corp.

K number K950949

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GKZ 1995-07-05

OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES

Applicant Immunotech, Inc.

K number K952182

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GKZ 1995-06-20

CALTAG CD4 R-PE MONOCLONAL ANTIBODY

Applicant Caltag Laboratories, Inc.

K number K944128

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GKZ 1995-06-20

CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY

Applicant Caltag Laboratories, Inc.

K number K944127

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GKZ 1995-06-20

CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES

Applicant Caltag Laboratories, Inc.

K number K944126

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GKZ 1995-06-09

SYSMEX(TM) F-820, 520

Applicant Sysmex Corp.

K number K945837

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GKZ 1995-05-15

TRAX(TM) CD4 TEST KIT

Applicant T Cell Diagnostics, Inc.

K number K925255

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GKZ 1995-05-05

OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES

Applicant Immunotech Corp.

K number K950626

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GKZ 1995-04-26

ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K941713

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GKZ 1995-04-26

ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K932532

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GKZ 1995-04-26

ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE

Applicant Ortho Diagnostic Systems, Inc.

K number K932531

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GKZ 1995-04-26

ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)

Applicant Ortho Diagnostic Systems, Inc.

K number K932530

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GKZ 1995-03-06

ONYX

Applicant Coulter Corp.

K number K943967

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GKZ 1995-02-03

SYSMEX K-4500

Applicant Sysmex Corp.

K number K943894

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GKZ 1995-01-25

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)

Applicant Dako Corp.

K number K945692

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GKZ 1994-12-14

TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

Applicant Miles, Inc.

K number K941171

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GKZ 1994-11-21

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25

Applicant Dako Corp.

K number K944253

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GKZ 1994-11-21

MONOCLONAL MOUSE ANTI-HUMAN B-CELL

Applicant Dako Corp.

K number K943284

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GKZ 1994-11-10

MONOCLONAL MOUSE ANTI-HUMAN T-CELL

Applicant Dako Corp.

K number K942797

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GKZ 1994-10-27

GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION

Applicant Alicia Diagnostics, Inc.

K number K925909

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GKZ 1994-09-30

AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS

Applicant Becton Dickinson Immunocytometry Systems

K number K925274

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GKZ 1994-09-09

FASCOUNT SYSTME

Applicant Becton Dickinson Immunocytometry Systems

K number K933486

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GKZ 1994-05-02

SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER

Applicant Toa Medical Electronics USA, Inc.

K number K936023

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GKZ 1993-11-22

TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11

Applicant Miles, Inc.

K number K933478

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GKZ 1993-11-22

TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11

Applicant Miles, Inc.

K number K933475

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GKZ 1993-09-01

FACSORT FLOW CYTOMETER

Applicant Becton Dickinson Immunocytometry Systems

K number K923790

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GKZ 1993-08-23

COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY

Applicant Coulter Corp.

K number K932030

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GKZ 1993-08-23

COULTER MH015 (DIFFERENTIAL CELL COUNTER)

Applicant Coulter Corp.

K number K930913

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GKZ 1993-08-05

SIMULTEST CD3/ANTI-HLA-DR

Applicant Becton Dickinson Immunocytometry Systems

K number K924587

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GKZ 1993-07-14

ABBOTT ENCOUNTER(TM)Q

Applicant Abbott Laboratories

K number K930309

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GKZ 1993-07-06

CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON

Applicant Coulter Corp.

K number K926124

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GKZ 1993-05-11

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)

Applicant Heraeus Kulzer, Inc.

K number K930148

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GKZ 1993-02-05

BIOVATION K-MANAGER

Applicant Biovation, Inc.

K number K925528

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GKZ 1993-02-05

CELLEXIS HEMATOLOGY ANALYZER

Applicant Technalysis, Inc.

K number K923773

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GKZ 1993-02-05

CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1

Applicant Coulter Immunology

K number K922745

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GKZ 1993-02-05

CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1

Applicant Coulter Immunology

K number K922744

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GKZ 1993-01-21

COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA

Applicant Coulter Corp.

K number K925344

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GKZ 1992-12-29

CD4 CYTOSPHERES KIT

Applicant Coulter Electronics, Inc.

K number K921279

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GKZ 1992-09-11

TECHNICON H*2

Applicant Heraeus Kulzer, Inc.

K number K923237

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GKZ 1992-08-17

COULTER MH009

Applicant Coulter Electronics, Inc.

K number K922181

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GKZ 1992-07-28

MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM

Applicant Gen Trak, Inc.

K number K922085

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GKZ 1992-07-28

MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM

Applicant Gen Trak, Inc.

K number K922084

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GKZ 1992-07-27

COULTER MAXM W/ AUTOLOADER

Applicant Coulter Electronics, Inc.

K number K922704

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GKZ 1992-07-06

COULTER MH017

Applicant Coulter Electronics, Inc.

K number K921567

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GKZ 1992-06-19

CD4 MONOCLONAL ANTIBODIES

Applicant Gen Trak, Inc.

K number K914848

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GKZ 1992-06-19

CD2 MONOCLONAL ANTIBODIES

Applicant Gen Trak, Inc.

K number K914846

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GKZ 1992-05-15

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5

Applicant Heraeus Kulzer, Inc.

K number K920949

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GKZ 1992-04-29

SYSMEX HEMATOLOGY SYSTEM ACCESSORIES

Applicant Toa Medical Electronics USA, Inc.

K number K920544

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GKZ 1992-02-06

SIMULTEST(TM) IMK-LYMPHOCYTE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K913192

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GKZ 1992-01-17

DIFFERENTIAL COUNTING BOARD

Applicant Biovation, Inc.

K number K915071

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GKZ 1991-12-30

SYSMEX NE-1500, MODIFICATION

Applicant Toa Medical Electronics USA, Inc.

K number K914744

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GKZ 1991-12-04

FACSTRAK FLOW CYTOMETER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K914014

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GKZ 1991-11-22

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER

Applicant Unipath , Ltd.

K number K913305

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GKZ 1991-10-31

CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC

Applicant Coulter Immunology

K number K910473

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GKZ 1991-10-31

MONOCLONAL ANTIBODY ANTI-CD3

Applicant Sigma Chemical Co.

K number K901189

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GKZ 1991-10-31

MONOCLONAL ANTIBODY ANTI-CD5

Applicant Sigma Chemical Co.

K number K901188

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GKZ 1991-10-31

MONOCLONAL ANTIBODY ANTI-CD2

Applicant Sigma Chemical Co.

K number K901187

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GKZ 1991-10-31

MONOCLONAL ANTIBODY ANTI-CD19

Applicant Sigma Chemical Co.

K number K901186

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GKZ 1991-10-08

NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL

Applicant Nova Biomedical Corp.

K number K913259

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GKZ 1991-09-13

SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER

Applicant Serono Baker Diagnostics System

K number K911626

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GKZ 1991-07-09

COULTERCLONE

Applicant Coulter Immunology

K number K911793

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GKZ 1991-06-17

COULTER(R) MH010

Applicant Coulter Electronics, Inc.

K number K911385

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GKZ 1991-05-20

ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY

Applicant Ortho Diagnostic Systems, Inc.

K number K904253

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GKZ 1991-05-07

QBC AUTOREADER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K910834

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GKZ 1991-04-12

DANAM DATACELL-18

Applicant Danam Electronics

K number K910283

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GKZ 1990-12-17

ANTI-HUMAN LEU-2A (CD8) PE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K904390

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GKZ 1990-12-11

SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K904209

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GKZ 1990-10-04

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY

Applicant Unipath , Ltd.

K number K903665

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GKZ 1990-05-15

ANTI-HUMAN LEU-3A (CD4) FITC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K900802

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GKZ 1990-04-16

RDW AND MPV INDICES ON HEMAT 12

Applicant Texas Intl. Laboratories, Inc.

K number K900684

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GKZ 1990-04-16

EXACT ONE(TM) HEMATOLOGY ANALYZER

Applicant Exact Science, Inc.

K number K900276

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GKZ 1990-04-02

SIMULTEST IMK PLUS(TM)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K900078

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GKZ 1990-03-30

COULTER JT3

Applicant Coulter Corp.

K number K896873

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GKZ 1990-03-14

TECHNICON H*2(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K900593

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