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) |
|---|---|---|---|
| Sep 2, 2010 | Abbott Laboratories CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | K051215 |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | K061667 |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | K991605 |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | K972354 |
| Sep 1, 2010 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis
System Terminated |
GKZ | K081930 |
| Sep 1, 2010 | Beckman Coulter Inc. COULTER LH 500 Series System Terminated |
GKZ | K032000 |
| Jun 30, 2010 | BD Biosciences, Systems & Reagents BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis Terminated |
GKZ | K050191 |
| Jun 25, 2010 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System,
Part number(s): 629029 Terminated |
GKZ | K081930 |
| May 26, 2010 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient pop Terminated |
GKZ | K081930 |
| May 26, 2010 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu Terminated |
GKZ | K081930 |
| May 26, 2010 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in Terminated |
GKZ | K081930 |
| May 26, 2010 | Beckman Coulter Inc. Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories Terminated |
GKZ | K032000 |
| May 20, 2010 | Abbott Laboratories CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA Terminated |
GKZ | K030513 |
| May 20, 2010 | Abbott Laboratories CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA Terminated |
GKZ | K870233 |
| May 20, 2010 | Abbott Laboratories CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA Terminated |
GKZ | K870233 |
| Apr 16, 2010 | BD Biosciences, Systems & Reagents BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166,
Product is manufactured and distributed by BD Biosciences, San Jose, CA
The reagents are for in v Terminated |
GKZ | K081213 K933486 |
| Oct 19, 2009 | Abbott Laboratories CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA.
Automated analyzer intended for in-vitro diagnostic use in the clinical labo Terminated |
GKZ | K081495 |
| May 22, 2009 | Abbott Laboratories Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA.
Product is a multi-parameter automated hemato Terminated |
GKZ | K061667 |
| Apr 23, 2009 | Abbott Laboratories Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA. Terminated |
GKZ | K051215 |
| Apr 10, 2009 | Abbott Laboratories CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01
The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instr Terminated |
GKZ | K061667 |
| Jan 13, 2009 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties o Terminated |
GKZ | K030828 |
| Jan 7, 2009 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 Terminated |
GKZ | K030828 |
| Nov 21, 2008 | Abbott Laboratories CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03
A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cell Terminated |
GKZ | K051215 |
| Aug 21, 2008 | Abbott Laboratories CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CA
For in vitro diagnostic use in counting and characte Terminated |
GKZ | K051215 |
| Aug 16, 2008 | BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609
Flexible data acquistion and analysis package specifically designed for digital-based Terminated |
GKZ | K062087 |
| Aug 8, 2008 | BD Biosciences BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System
Model/Catalog number 642685
Software is used to simplify acquisition of flow cytometry data. Terminated |
GKZ | K040725 K062087 |
| Aug 8, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628
A system for the qualitative and quantitative measurement of biological and physical pr Terminated |
GKZ | K030828 |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 15 User Network, Automated differential cell counter; Part Number 774180; Beckman Coulter; Mi Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 10 User Network, Automated differential cell counter; Part Number 774179; Beckman Coulter; Mi Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated differential cell counter; Part Number 774178; Beckman Coulter; Mia Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 15 User, Automated differential cell counter; Part Number 774201; Beckman Coulter; Miami, FL Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User, Automated differential cell counter; Part Number 774200; Beckman Coulter; Miami, FL 3 Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3 User, Automated differential cell counter; Part Number 774199; Beckman Coulter; Miami, FL 3 Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2 Single User Upgrade, Automated differential cell counter; Part Number 774198; Beckman Coulter; Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2 Single User, Automated differential cell counter; Part Number 774197; Beckman Coulter; Miami, Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 network user with Romlock, Automated differential cell counter; Part Number 722595; Beckman Coult Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 10 network user with Romlock, Automated differential cell counter; Part Number 722594; Beckman Coult Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 network user with Romlock, Automated differential cell counter; Part Number 722593; Beckman Coulte Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 User Pack, Automated differential cell counter; Part Number 722399; Beckman Coulter; Miami, FL 33 Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 User Pack, Automated differential cell counter; Part Number 722398; Beckman Coulter; Miami, FL 331 Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 3 User Pack, Automated differential cell counter; Part Number 722397; Beckman Coulter; Miami, FL 331 Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1 single user upgrade, Automated differential cell counter; Part Number 722395; Beckman Coulter; Miami, Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1 single user, Automated differential cell counter; Part Number 722396; Beckman Coulter; Miami, FL 3319 Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 120V, Automated differential cell counter; Part Number 6605628; Beckman Coulter; Miami, FL 33196. Terminated |
GKZ | None listed |
| Jul 11, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 with UPS, Automated differential cell counter; Part Number: 626553; Beckman Coulter; Miami, FL 33196. Terminated |
GKZ | None listed |
| Apr 30, 2008 | Beckman Coulter Inc Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834 Terminated |
GKZ | K030828 |
| Apr 30, 2008 | Beckman Coulter Inc Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834 Terminated |
GKZ | K071681 |
| Apr 24, 2008 | Abbott Laboratories CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL. Terminated |
GKZ | K051215 |
| Mar 13, 2008 | Abbott Laboratories Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113 Terminated |
GKZ | K030513 |
| Mar 4, 2008 | BD Biosciences BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131. Terminated |
GKZ | K963963 |
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