ClearanceBrief
Panels › Hematology › Product code GKZ · Class 2

Counter, Differential Cell

Regulation 864.5220

4510(k)s in 12 months (381 all time)
1recalls in 12 months (247 all time)
211recalls that name a 510(k)
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Top companies in GKZ

Company510(k)sRecalls
Beckman Coulter28123
Abbott Laboratories2454
Sysmex America, Inc.225
Siemens Healthcare Diagnostics323
Coulter Corp.230
Becton Dickinson Immunocytometry Systems210
Ortho Diagnostic Systems, Inc.160
Bd Becton Dickinson Vacutainer Systems Preanalytic150
Abx Diagnostics95
Coulter Electronics, Inc.140
Decided510(k)Device and applicantCode
Sep 14, 2026K260781Yumizen H550
HORIBA ABX SAS, FR
GKZ
May 27, 2026K253212XR-Series (XR-10, XR-20) Automated Hematology Analyzers
Sysmex America, Inc.
GKZ
Feb 6, 2026K243348Athelas Home
Athelas, Inc.
GKZ
Jan 16, 2026K251249Tru Hematology Test
Truvian Sciences, Inc.
GKZ
Jun 25, 2025K251371Sysmex XR-Series (XR-20) Automated Hematology Analyzer
Sysmex America, Inc.
GKZ
Jun 25, 2025K250943Sysmex XR-Series (XR-10) Automated Hematology Analyzer
Sysmex America, Inc.
GKZ
Feb 20, 2025K243283Alinity h-series System
Abbott Laboratories
GKZ
Feb 3, 2025K240402Cito CBC System
Cytochip, Inc.
GKZ
Jul 5, 2024K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniC
Beckman Coulter, Inc.
GKZ
May 21, 2024K232946Yumizen H2500
HORIBA ABX SAS, FR
GKZ
May 2, 2024K240636HemoScreen Hematology Analyzer
Pixcell Medical Technologies, IL
GKZ
Dec 21, 2023K230887Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Sysmex America, Inc.
GKZ
Nov 14, 2023K230878QScout Lab; QScout RLD
Ad Astra Diagnostics, Inc.
GKZ
Aug 16, 2023K222148HemoScreen Hematology Analyzer
Pixcell Medical Technologies, Ltd., IL
GKZ
Aug 4, 2023K220031Alinity h-series System
Abbott Laboratories
GKZ
Nov 8, 2022K210346Sysmex XW-100 Automated Hematology Analyzer
Sysmex America, Inc.
GKZ
May 9, 2022K211840Sight OLO
S.D. Sight Diagnostics , Ltd., IL
GKZ
Mar 22, 2022K200828Athelas Home
Athelas, Inc.
GKZ
Apr 16, 2020K193124Unicel DxH 800 Coulter Cellular Analysis System
Beckman Coulter
GKZ
Nov 1, 2019K190898Sight OLO
Sight Diagnostics , Ltd., IL
GKZ
Sep 6, 2019K182886Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
Beckman Coulter
GKZ
Mar 15, 2019K190294CELL-DYN Emerald 22 AL System
Abbott Laboratories
GKZ
Mar 1, 2019K181475DxH 520 Hematology Instrument
Beckman Coulter
GKZ
Jan 25, 2019K182389Sysmex XN-L Automated Hematology Analyzer
Sysmex America, Inc.
GKZ
Nov 5, 2018K181288Athelas One
Athelas, Inc.
GKZ
Oct 29, 2018K180020HemoScreen Hematology Analyzer
Pixcell Medical Technologies, Ltd., IL
GKZ
Mar 2, 2018K171655cobas m 511 integrated hematology analyzer
Roche Diagnostics Hematology, Inc.
GKZ
Nov 6, 2017K172604XW-100 Automated Hematology Analyzer for CLIA Waived Use
Sysmex America, Inc.
GKZ
Nov 1, 2017K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
HORIBA ABX SAS, FR
GKZ
Aug 11, 2017K162977ADVIA 2120i, ADVIA 2120
Siemens Healthcare Diagnostics
GKZ
Mar 2, 2017K153538Dextramer CMV Kit
Immudex Aps, DK
GKZ
Dec 22, 2016K160538Sysmex XN-L Automated Hematology Analyzer
Sysmex America, Inc.
GKZ
Nov 29, 2016K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
Beckman Coulter, Inc.
GKZ
Sep 1, 2016K160429BC-5390 Auto Hematology Analyzer
Mindray Bio-Medical Electronics Co., Ltd., CN
GKZ
Dec 9, 2015K151133PENTRA XLR
HORIBA ABX SAS, FR
GKZ
Oct 12, 2015K143577XW-100 Automated Hematology Analyzer, XW QC CHECK
Sysmex America, Inc.
GKZ
Aug 21, 2015K143348BC-3600 Auto Hematology Analyzer
Mindray Bio-Medical Electronics Co., Ltd., CN
GKZ
Dec 20, 2014K141161ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
HORIBA ABX SAS, FR
GKZ
Dec 5, 2014K141681SYSMEX XN SERIES
Sysmex America, Inc.
GKZ
Sep 5, 2014K140911UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
Beckman Coulter, Inc.
GKZ
Mar 22, 2013K120771UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Beckman Coulter, Inc.
GKZ
Oct 19, 2012K112605SYSMEX XN-SERIES
Sysmex America, Inc.
GKZ
Aug 2, 2012K111534ABACUS 3CP
Diatron U.S., Inc.
GKZ
Mar 27, 2012K112755ABACUS 5
Diatron U.S., Inc.
GKZ
Dec 22, 2011K110381CELL-DYN EMERALD 22 SYSTEM
Abbott Laboratories
GKZ
Nov 23, 2011K102644ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
Siemens Healthcare Diagnostics
GKZ
Mar 7, 2011K102064BD FACS SAMPLE PREP ASSISTANT III (SPA III)
Becton, Dickinson & CO
GKZ
Oct 26, 2010K100489DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
Beckman Coulter Cellular
GKZ
Jul 28, 2010K090346ADVIA 2120/2120I BODY FLUIDS
Siemens Healthcare Diagnostics
GKZ
Apr 8, 2010K093394BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
GKZ

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