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
DateFirm and productCodeLinked 510(k)
Nov 20, 2018Beckman Coulter Inc.
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Terminated		 GKZK963263
K990172
Nov 20, 2018Beckman Coulter Inc.
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
Terminated		 GKZK030828
K071681
Nov 3, 2017Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
Terminated		 GKZK140911
Nov 3, 2017Beckman Coulter Inc.
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand,
Terminated		 GKZK140911
Nov 3, 2017Beckman Coulter Inc.
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Terminated		 GKZK140911
Jun 26, 2017Beckman Coulter Inc.
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs addit
Terminated		 GKZK010765
Jun 26, 2017Beckman Coulter Inc.
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in
Terminated		 GKZK011342
K022161 +4
Jun 20, 2017Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to use
Terminated		 GKZK140911
Apr 24, 2017Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
Terminated		 GKZK081930
K120771 +1
Apr 24, 2017Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
Terminated		 GKZK081930
K120771 +1
Apr 21, 2017JAS Diagnostics Inc.
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Terminated		 GKZK071562
Apr 14, 2017Sysmex America Inc
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Terminated		 GKZK112605
K141681
Mar 9, 2017Abbott Laboratories
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Terminated		 GKZK061667
Jan 11, 2017Beckman Coulter Inc.
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Terminated		 GKZK081930
K120771 +1
Jan 11, 2017Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Terminated		 GKZK081930
K120771 +1
Oct 21, 2016Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Terminated		 GKZK111534
K112755
Sep 2, 2016Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Ce
Terminated		 GKZK140911
Aug 9, 2016Becton, Dickinson and Company, BD Biosciences
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isot
Terminated		 GKZK071143
Jun 24, 2016Becton, Dickinson and Company, BD Biosciences
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
Terminated		 GKZK970836
Jun 10, 2016Sysmex Corporation
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratorie
Terminated		 GKZK112605
Apr 19, 2016Abbott Laboratories
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer
Terminated		 GKZK081495
Mar 31, 2016Becton, Dickinson and Company, BD Biosciences
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro
Terminated		 GKZK970836
Mar 10, 2016Jas Diagnostics/Drew Scientific
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Terminated		 GKZK071562
Mar 10, 2016Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical
Terminated		 GKZK111534
Dec 16, 2015Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-
Terminated		 GKZK081930
K120771 +1
Dec 16, 2015Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in
Terminated		 GKZK081930
K120771 +1
Dec 16, 2015Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology
Terminated		 GKZK081930
K120771 +1
Sep 24, 2015Becton, Dickinson and Company, BD Biosciences
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell s
Terminated		 GKZK900802
Jul 16, 2015BD Biosciences, Systems & Reagents
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway
Terminated		 GKZK040725
K041074 +3
Aug 14, 2014BD Biosciences, Systems & Reagents
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
Terminated		 GKZK982231
Jun 20, 2014Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Terminated		 GKZK081930
Jun 20, 2014Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Terminated		 GKZK081930
K120771
Dec 10, 2013Beckman Coulter Inc.
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter
Terminated		 GKZK061616
Dec 10, 2013Beckman Coulter Inc.
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter
Terminated		 GKZK011342
Nov 4, 2013Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in scree
Terminated		 GKZK081930
K120771
Nov 1, 2013Beckman Coulter Inc.
COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical
Terminated		 GKZK011342
K061616
Oct 18, 2013Sysmex America Inc
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. W
Terminated		 GKZK032677
Oct 17, 2013Siemens Healthcare Diagnostics
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 212
Terminated		 GKZK102644
Nov 6, 2012Sysmex America, Inc.
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-23
Terminated		 GKZK051457
Nov 6, 2012Sysmex America, Inc.
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-759
Terminated		 GKZK071967
Nov 6, 2012Sysmex America, Inc.
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-134
Terminated		 GKZK992875
Oct 10, 2012Beckman Coulter Inc.
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3
Terminated		 GKZK030828
Oct 10, 2012Beckman Coulter Inc.
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8
Terminated		 GKZK030408
Oct 10, 2012Beckman Coulter Inc.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+
Terminated		 GKZK030408
Oct 9, 2012Beckman Coulter Inc.
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu
Terminated		 GKZK081930
Sep 17, 2012BD Biosciences, Systems & Reagents
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACS
Terminated		 GKZK040026
Mar 21, 2012Beckman Coulter Inc.
COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500 Series System 240V, PN 178834;
Terminated		 GKZK032000
Mar 21, 2012Beckman Coulter Inc.
COULTER LH 750 Analyzer, part number: LH750 System Help 2D1.103272, PN 6605632, PN 6605632R & PN A85570. SW Version 2D1, 2D2. Serial Number: all. The COULTER LH 750 Hematology Analyzer is a quant
Terminated		 GKZK011342
Mar 21, 2012Beckman Coulter Inc.
COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: 1B1, 1B2. Serial Number: all. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hemat
Terminated		 GKZK061616
Mar 8, 2012Pointcare Technologies, Inc.
PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positi
Terminated		 GKZK072869

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