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) |
|---|---|---|---|
| Jan 11, 2012 | Beckman Coulter Inc. COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader
Part number: 6705995, 6705996, 6705997/
Part number: 6705998, 67059999, 6706000.
HmX Hematology Analyzer / HmX Hematology An Terminated |
GKZ | K922704 |
| Jan 11, 2012 | Beckman Coulter Inc. Coulter HmX Hematology Analyzer with Autoloader,
Part number: 6605525, 6605526, 6605527.
HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematol Terminated |
GKZ | K010765 |
| Jan 11, 2012 | Beckman Coulter Inc. Coulter HmX Hematology Analyzer,
Part number: 6605522, 6605523, 6605524.
HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is Terminated |
GKZ | K010765 |
| Jan 11, 2012 | Beckman Coulter Inc. Coulter LH500 Series Analyzer,
Part number: 178832, 178833, 178834.
LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated hematology a Terminated |
GKZ | K032000 |
| Sep 1, 2011 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System
Product Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD The UniCel DxH 800 Analyzer is a quantitative, automate Terminated |
GKZ | K081930 |
| May 20, 2011 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System.
A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Terminated |
GKZ | K081930 |
| May 10, 2011 | Beckman 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 |
GKZ | K081930 |
| May 9, 2011 | Beckman 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 |
GKZ | K081930 |
| May 5, 2011 | Beckman 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 popul Terminated |
GKZ | K081930 |
| May 5, 2011 | Beckman 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 pop Terminated |
GKZ | K081930 |
| May 2, 2011 | Beckman 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 popul Terminated |
GKZ | K081930 |
| Apr 29, 2011 | Beckman 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 popul Terminated |
GKZ | K081930 |
| Apr 29, 2011 | Beckman 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 |
GKZ | K081930 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Sheer Valve Assembly Driver
Abbott Diagnostics Division, Santa Clara, CA 05054 Terminated |
GKZ | K991605 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer.
Abbott Diagnostics Division, Santa Clara, CA 05054 Terminated |
GKZ | K061667 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | K972354 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | K972354 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | K991605 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | K991605 |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | K991605 |
| Apr 20, 2011 | Beckman Coulter Inc. COULTER HmX Hematology Analyzer
with Autoloader
Part number: 6605525, 6605526, 6605527
The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential Terminated |
GKZ | K010765 |
| Apr 20, 2011 | Beckman Coulter Inc. COULTER HmX Hematology Analyzer
Part number: 6605522, 6605523, 6605524
The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter fo Terminated |
GKZ | K010765 |
| Apr 20, 2011 | Beckman Coulter Inc. COULTER LH 500 Series Analyzer
Part number: 178832, 178833, 178834
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro D Terminated |
GKZ | K032000 |
| Apr 14, 2011 | Beckman Coulter Inc. UniCel DxH 800 Floor Cabinet Part Number: 723335
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clin Terminated |
GKZ | K081930 |
| Apr 14, 2011 | Beckman Coulter Inc. COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial
Numbers(s): All Serial Numbers
The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully auto Terminated |
GKZ | K030291 |
| Apr 13, 2011 | Beckman Coulter Inc. UniCel DxH 800 Floor Cabinet Part Number: 723335
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in cli Terminated |
GKZ | K081930 |
| Apr 13, 2011 | Beckman 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 popul Terminated |
GKZ | K081930 |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter LH500 Series System
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Terminated |
GKZ | K032000 |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter LH780 Analyzer
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. Terminated |
GKZ | K061616 |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter LH750 Analyzer
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. Terminated |
GKZ | K011342 |
| Apr 6, 2011 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound System with software versions:
VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461;
Product is manufactured and distributed by Siemens Medical Solutions USA, Terminated |
GKZ | K082142 |
| Apr 4, 2011 | Beckman 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+/CD Terminated |
GKZ | K030408 |
| Apr 4, 2011 | Beckman 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 |
GKZ | K030408 |
| Mar 30, 2011 | BD Biosciences, Systems & Reagents CellQuest Pro SW, version 4.0.2. and later;
Becton Dickinson, San Jose, CA 95131
CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer. Terminated |
GKZ | K946055 |
| Mar 18, 2011 | Beckman Coulter Inc. Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader.
Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000.
Quantita Terminated |
GKZ | K911385 |
| Mar 18, 2011 | Beckman Coulter Inc. Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader.
Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564.
Quantitative Terminated |
GKZ | K010765 |
| Mar 18, 2011 | Abbott Laboratories Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL
The CE Terminated |
GKZ | K081495 |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer for in vitro diagnostic use in clinica Terminated |
GKZ | None listed |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer for in vitro diagnostic use Terminated |
GKZ | K980614 |
| Mar 17, 2011 | Abbott Laboratories Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02,
Product is manufactured and distributed by
Abbott Diagnostics Division, Santa Clara. CA
Designed for use on the CELL-DYN Terminated |
GKZ | K081495 |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer for in Terminated |
GKZ | K991605 |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer for i Terminated |
GKZ | K972354 |
| Mar 17, 2011 | Abbott Laboratories The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems.
Usage: Accessories to human waste container systems Terminated |
GKZ | K030513 K870233 +4 |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader), Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer Terminated |
GKZ | K991605 |
| Mar 11, 2011 | Abbott Laboratories CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA
Medical dev Terminated |
GKZ | K961439 |
| Feb 10, 2011 | Abbott Laboratories Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System;
List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902;
Product is distributed by
Abbott Dia Terminated |
GKZ | K081495 |
| Jan 8, 2011 | Varian Medical Systems Oncology Systems Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alt Terminated |
GKZ | K070094 K904364 +1 |
| Nov 29, 2010 | Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers;
CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02,
CELL-DYN Sapphire Accessory Kit, List Number: Terminated |
GKZ | None listed |
| Nov 3, 2010 | BD Biosciences, Systems & Reagents BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA.
The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow Terminated |
GKZ | None listed |
| Sep 14, 2010 | Abbott Laboratories CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA Terminated |
GKZ | K051215 |
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