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)
Top companies in GKZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2008 | Beckman Coulter Inc Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835 Terminated |
GKZ | K954688 |
| Jan 4, 2008 | Abbott Laboratories Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wr Terminated |
GKZ | K051215 |
| Dec 22, 2007 | Beckman Coulter Inc COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKZ | K032000 |
| Dec 22, 2007 | Beckman Coulter Inc COULTER LH780 Analyzer , Part Number: 723585, Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKZ | K061616 |
| Dec 22, 2007 | Beckman Coulter Inc COULTER LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKZ | K011342 |
| Aug 29, 2007 | Abbott Laboratories Abbott CELL-DYN 3700 Hematology Analyzer Terminated |
GKZ | K980614 K991605 |
| Aug 29, 2007 | Abbott Laboratories Abbott CELL-DYN 3500 Hematology Analyzer Terminated |
GKZ | K913305 K955715 +3 |
| Aug 29, 2007 | Abbott Laboratories Abbott CELL-DYN 3000 Hematology Analyzer Terminated |
GKZ | K890491 K955673 +1 |
| Aug 18, 2007 | Abbott Laboratories Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 Terminated |
GKZ | K870233 |
| Aug 18, 2007 | Abbott Laboratories CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when Terminated |
GKZ | K870233 |
| Mar 6, 2007 | Beckman Coulter Inc Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5) Terminated |
GKZ | K011342 |
| Feb 8, 2007 | Beckman Coulter Inc CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Softwar Terminated |
GKZ | K030828 |
| Feb 8, 2007 | Beckman Coulter Inc Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418 SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC Upgrade Kit; 771938 MXP 2.1 S Terminated |
GKZ | K030828 |
| Feb 8, 2007 | Beckman Coulter Inc Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version Terminated |
GKZ | K030828 |
| Jan 9, 2007 | Drew Scientific Group PLC Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | K991539 |
| Jan 9, 2007 | Drew Scientific Group PLC Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | K991539 |
| Jan 5, 2007 | Drew Scientific Group PLC Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | K991539 |
| Jan 5, 2007 | Drew Scientific Group PLC Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. Terminated |
GKZ | K991539 |
| Dec 27, 2006 | Beckman Coulter Inc FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit Terminated |
GKZ | None listed |
| Nov 21, 2006 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1 Terminated |
GKZ | K030828 |
| Aug 3, 2006 | ABX Diagnostics Inc ABX Pentra 120,120R,120DX, automated hematology analyzer Terminated |
GKZ | K022200 K050719 |
| Feb 16, 2006 | Abbott Laboratories CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer Terminated |
GKZ | K010953 |
| Feb 4, 2006 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzer, PN
6605632 and 6605632R Terminated |
GKZ | K011342 |
| Dec 23, 2005 | ABX Diagnostics Inc Pentra 80 and Pentra 80XL Hematology Analyzers Terminated |
GKZ | None listed |
| Dec 6, 2005 | Abbott Laboratories Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers,
List Numbers:
99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle);
Product is distributed by Abbott Hematology, 5440 Patrick Terminated |
GKZ | None listed |
| Aug 17, 2005 | Beckman Coulter Inc Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0 Terminated |
GKZ | None listed |
| Jul 22, 2005 | Beckman Coulter Inc Beckman Coulter 1500 Series Hematology Automation System;
Part Number:
988609 (LH Basic Uint)
988610 (LH Connection Unit) Terminated |
GKZ | None listed |
| Feb 10, 2005 | Beckman Coulter Inc COULTER LH 750 Hematology Analyzer. Terminated |
GKZ | None listed |
| Dec 21, 2004 | Beckman Coulter Inc ACT diff 2 Analyzer
(Automated differential cell counter) Terminated |
GKZ | K990352 |
| Nov 30, 2004 | Beckman Coulter Inc CXP software for Cytomics FC500 Cytometer Terminated |
GKZ | None listed |
| Nov 30, 2004 | Beckman Coulter Inc CXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer.
Part numbers: 624281, 623560, 623563, 623554, 623555, 623541, 623556, 623557, 623558, 623559. Terminated |
GKZ | None listed |
| Oct 5, 2004 | ABX Diagnostics Inc Automated Differential Cell Counter Terminated |
GKZ | K024002 |
| Oct 5, 2004 | ABX Diagnostics Inc Automated Differential Cell Counter Terminated |
GKZ | K024002 |
| Sep 2, 2004 | Beckman Coulter Inc COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differenti Terminated |
GKZ | K032000 |
| Jul 20, 2004 | Beckman Coulter Inc Coulter AcT 5diff Autoloader (AL) Hematology Analyzer Terminated |
GKZ | K030291 |
| Jul 20, 2004 | Beckman Coulter Inc Coulter LH750 Hematology Analyzer. Part Number 6605632. Terminated |
GKZ | K011342 |
| Oct 15, 2003 | Beckman Coulter Inc Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent Terminated |
GKZ | None listed |
| Oct 15, 2003 | Beckman Coulter Inc Coulter AcT 5diff Cap Pierce Hematology Analyzers
Part Numbers: 6605641, 6605705 Terminated |
GKZ | None listed |
| Oct 15, 2003 | Beckman Coulter Inc Coulter AcT 5diff Open Vial Hematology Analyzers
Part Numbers: 6605580, 6605581, 6605604 Terminated |
GKZ | K992511 |
| Aug 21, 2003 | ABX Diagnostics Inc ABX Diagnostices Pentra 60C+ Hematology Analyzer Terminated |
GKZ | K003677 |
| Mar 21, 2003 | Beckman Coulter Inc LH 700 Series Hematology Analyzers.
Part numbers 66056032, 6605633, 6605645 Terminated |
GKZ | K011342 |
| Mar 13, 2003 | Abbott Laboratories Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT
Model/List Number 01H73-01 Terminated |
GKZ | K010953 K961439 +2 |
| Feb 5, 2003 | Beckman Coulter Inc Coulter LH 700 Series Hematology Analyzers Terminated |
GKZ | K011342 |
| Jan 9, 2003 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzers Terminated |
GKZ | None listed |
| Jan 9, 2003 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzers Terminated |
GKZ | None listed |
| Jan 9, 2003 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzers Terminated |
GKZ | None listed |
| Jan 9, 2003 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzers Terminated |
GKZ | K011342 K022161 |
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