Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2026-09-14

Yumizen H550

Applicant HORIBA ABX SAS

K number K260781

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GKZ 2026-05-27

XR-Series (XR-10, XR-20) Automated Hematology Analyzers

Applicant Sysmex America, Inc.

K number K253212

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GKZ 2026-02-06

Athelas Home

Applicant Athelas, Inc.

K number K243348

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GKZ 2026-01-16

Tru Hematology Test

Applicant Truvian Sciences, Inc.

K number K251249

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GKZ 2025-06-25

Sysmex XR-Series (XR-20) Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K number K251371

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GKZ 2025-06-25

Sysmex XR-Series (XR-10) Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K number K250943

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GKZ 2025-02-20

Alinity h-series System

Applicant Abbott Laboratories

K number K243283

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GKZ 2025-02-03

Cito CBC System

Applicant Cytochip, Inc.

K number K240402

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GKZ 2024-07-05

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

Applicant Beckman Coulter, Inc.

K number K240252

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GKZ 2024-05-21

Yumizen H2500

Applicant HORIBA ABX SAS

K number K232946

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GKZ 2024-05-02

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies

K number K240636

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GKZ 2023-12-21

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K number K230887

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GKZ 2023-11-14

QScout Lab; QScout RLD

Applicant Ad Astra Diagnostics, Inc.

K number K230878

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GKZ 2023-08-16

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies, Ltd.

K number K222148

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GKZ 2023-08-04

Alinity h-series System

Applicant Abbott Laboratories

K number K220031

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GKZ 2022-11-08

Sysmex XW-100 Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K number K210346

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GKZ 2022-05-09

Sight OLO

Applicant S.D. Sight Diagnostics , Ltd.

K number K211840

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GKZ 2022-03-22

Athelas Home

Applicant Athelas, Inc.

K number K200828

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GKZ 2020-04-16

Unicel DxH 800 Coulter Cellular Analysis System

Applicant Beckman Coulter

K number K193124

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GKZ 2019-11-01

Sight OLO

Applicant Sight Diagnostics , Ltd.

K number K190898

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GKZ 2019-09-06

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

Applicant Beckman Coulter

K number K182886

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GKZ 2019-03-15

CELL-DYN Emerald 22 AL System

Applicant Abbott Laboratories

K number K190294

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GKZ 2019-03-01

DxH 520 Hematology Instrument

Applicant Beckman Coulter

K number K181475

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GKZ 2019-01-25

Sysmex XN-L Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K number K182389

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GKZ 2018-11-05

Athelas One

Applicant Athelas, Inc.

K number K181288

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GKZ 2018-10-29

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies, Ltd.

K number K180020

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GKZ 2018-03-02

cobas m 511 integrated hematology analyzer

Applicant Roche Diagnostics Hematology, Inc.

K number K171655

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GKZ 2017-11-06

XW-100 Automated Hematology Analyzer for CLIA Waived Use

Applicant Sysmex America, Inc.

K number K172604

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GKZ 2017-11-01

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

Applicant HORIBA ABX SAS

K number K170353

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GKZ 2017-08-11

ADVIA 2120i, ADVIA 2120

Applicant Siemens Healthcare Diagnostics

K number K162977

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GKZ 2017-03-02

Dextramer CMV Kit

Applicant Immudex Aps

K number K153538

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GKZ 2016-12-22

Sysmex XN-L Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K number K160538

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GKZ 2016-11-29

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

Applicant Beckman Coulter, Inc.

K number K162414

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GKZ 2016-09-01

BC-5390 Auto Hematology Analyzer

Applicant Mindray Bio-Medical Electronics Co., Ltd.

K number K160429

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GKZ 2013-03-22

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

Applicant Beckman Coulter, Inc.

K number K120771

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GKZ 2012-10-19

SYSMEX XN-SERIES

Applicant Sysmex America, Inc.

K number K112605

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GKZ 2012-08-02

ABACUS 3CP

Applicant Diatron U.S., Inc.

K number K111534

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GKZ 2012-03-27

ABACUS 5

Applicant Diatron U.S., Inc.

K number K112755

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GKZ 2011-12-22

CELL-DYN EMERALD 22 SYSTEM

Applicant Abbott Laboratories

K number K110381

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GKZ 2011-11-23

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I

Applicant Siemens Healthcare Diagnostics

K number K102644

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GKZ 2011-03-07

BD FACS SAMPLE PREP ASSISTANT III (SPA III)

Applicant Becton, Dickinson & CO

K number K102064

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GKZ 2010-10-26

DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771

Applicant Beckman Coulter Cellular

K number K100489

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GKZ 2010-07-28

ADVIA 2120/2120I BODY FLUIDS

Applicant Siemens Healthcare Diagnostics

K number K090346

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GKZ 2010-04-08

BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K093394

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GKZ 2010-03-30

SYSMEX MODEL XT-4000I

Applicant Sysmex America, Inc.

K number K091313

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GKZ 2009-09-18

THERMO SCIENTIFIC CYTO-CAL COUNT TUBES

Applicant Microgenics Corp.

K number K090810

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GKZ 2009-07-31

BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611

Applicant Bd Biosciences

K number K090967

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GKZ 2009-04-21

CHEMPAQ XBC ANALYZER

Applicant Chempaq A/S

K number K090013

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GKZ 2009-04-15

TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00

Applicant Reametrix, Inc.

K number K082091

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GKZ 2009-02-04

CELL-DYN EMERALD SYSTEM

Applicant Abbott Laboratories

K number K081495

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GKZ 2009-02-03

MEDONIC M SERIES

Applicant Boule Medical AB

K number K083420

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GKZ 2008-12-19

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

Applicant Beckman Coulter, Inc.

K number K081930

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GKZ 2008-10-10

SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER

Applicant Sysmex America, Inc.

K number K081890

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GKZ 2008-08-29

SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER

Applicant Sysmex America, Inc.

K number K081610

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GKZ 2008-08-14

FLOWCARE TLG REAGENT

Applicant Beckman Coulter, Inc.

K number K081526

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GKZ 2008-08-14

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010

Applicant Bd Biosciences

K number K081213

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GKZ 2008-01-14

POINTCARE NOW SYSTEM

Applicant Pointcare Technologies, Inc.

K number K072869

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GKZ 2007-12-11

D3 HEMATOLOGY ANALYZER, MODEL D3

Applicant Drew Scientific, Inc.

K number K071562

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GKZ 2007-11-20

SYSMEX XE-5000

Applicant Sysmex America, Inc.

K number K071967

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GKZ 2007-10-04

CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554

Applicant Beckman Coulter, Inc.

K number K071681

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GKZ 2007-06-11

BC-3200 AUTO HEMATOLOGY ANALYZER

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K063407

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GKZ 2007-06-06

BD TRITEST CD3/CD4/CD45, MODEL 340383

Applicant Bd Biosciences

K number K071143

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GKZ 2007-06-06

BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402

Applicant Bd Biosciences

K number K071141

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GKZ 2006-10-04

COULTER LH 780 HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K061616

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GKZ 2006-09-14

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

Applicant Bd Biosciences

K number K062087

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GKZ 2006-08-15

CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES

Applicant Dakocytomation California, Inc.

K number K060423

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GKZ 2006-07-21

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

Applicant Beckman Coulter, Inc.

K number K061574

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GKZ 2006-07-10

CELL-DYN RUBY SYSTEM

Applicant Abbott Laboratories

K number K061667

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GKZ 2006-07-06

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES

Applicant Sysmex America, Inc.

K number K061150

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GKZ 2006-06-06

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166

Applicant Bd Biosciences

K number K060375

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GKZ 2006-05-10

SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES

Applicant Sysmex America, Inc.

K number K060656

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GKZ 2006-04-14

GUAVA EZCD4 SYSTEM

Applicant Guava Technologies, Inc.

K number K053497

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GKZ 2005-12-29

ABX MICROS CRP 200, OPTION IM

Applicant Horiba Abx

K number K053308

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GKZ 2005-12-22

CHEMPAQ XBC ANALYZER

Applicant Chempaq A/S

K number K050758

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GKZ 2005-11-18

MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K052905

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GKZ 2005-09-23

SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER

Applicant Sysmex America, Inc.

K number K051459

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GKZ 2005-08-31

MS 4/5 HEMATOLOGY ANALYZER

Applicant Melet Schloesing Laboratories USA

K number K050421

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GKZ 2005-08-08

IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER

Applicant Sysmex America, Inc.

K number K051199

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GKZ 2005-08-01

ITAG MHC TETRAMER CMV ASSAY

Applicant Beckman Coulter, Inc.

K number K051122

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GKZ 2005-07-27

MS 9/5 HEMATOLOGY ANALYZER

Applicant Melet Schloesing Laboratories USA

K number K050436

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GKZ 2005-07-21

CELL-DYN SAPPHIRE SYSTEM

Applicant Abbott Laboratories

K number K051215

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GKZ 2005-05-04

RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER

Applicant Sysmex America, Inc.

K number K050589

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GKZ 2005-04-26

ABX PENTRA DX 120: OPTION SPS EVOLUTION

Applicant Horiba Abx

K number K050719

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GKZ 2005-02-10

COULTER LH 750 HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K050057

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GKZ 2005-01-19

FLOWCARE PLG CD4 REAGENT

Applicant Beckman Coulter, Inc.

K number K043215

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GKZ 2004-11-23

FLOWCARE SYSTEM

Applicant Pointcare Technologies, Inc.

K number K041882

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GKZ 2004-10-29

MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K042724

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GKZ 2004-10-12

COULTER A T 5DIFF CAP PIERCE (CP)

Applicant Beckman Coulter, Inc.

K number K042173

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GKZ 2004-09-17

BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM

Applicant Bayer Healthcare, LLC

K number K042251

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GKZ 2004-09-17

BD FACSCANTO WITH BD FACSANTO SOFTWARE

Applicant Bd Biosciences

K number K041074

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GKZ 2004-09-10

BD FACSCANTO SYSTEM

Applicant Becton Dickinson Immunocytometry Systems

K number K040725

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GKZ 2004-09-10

BD FACS 7-COLOR SETUP BEADS

Applicant Becton Dickinson Immunocytometry Systems

K number K040026

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GKZ 2004-03-18

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)

Applicant Sysmex America, Inc.

K number K040073

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GKZ 2004-01-29

MEDONIC CA620/530 HEMATOLOGY ANALYZER

Applicant Boule Medical AB

K number K032214

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GKZ 2003-11-24

IMMUNICON CELLTRACKS ANALYZER

Applicant Immunicon Corp.

K number K030263

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GKZ 2003-09-26

COULTER LH 750 HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K032342

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GKZ 2003-09-08

ADVIA 60 HEMATOLOGY ANALYZER

Applicant Bayer Healthcare, LLC

K number K032524

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GKZ 2003-09-08

IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER

Applicant Sysmex America, Inc.

K number K032039

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GKZ 2003-08-13

COULTER LH 500 HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K032000

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GKZ 2003-07-24

COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER

Applicant Beckman Coulter, Inc.

K number K032013

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