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

DateFirm and productCodeLinked 510(k)
Nov 12, 2025Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analy
Open, Classified
GKZK220031
K243283
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Open, Classified
GKZK120771
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Open, Classified
GKZK193124
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Open, Classified
GKZK240252
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Open, Classified
GKZK240252
Aug 1, 2025Becton, Dickinson and Company, BD Bio Sciences
BD Trucount Controls, 30 Test - REF: 340335
Open, Classified
GKZNone listed
Aug 1, 2025Becton, Dickinson and Company, BD Bio Sciences
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Open, Classified
GKZNone listed
Jul 3, 2025Becton, Dickinson and Company, BD Bio Sciences
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Open, Classified
GKZK040026
Jul 3, 2025Becton, Dickinson and Company, BD Bio Sciences
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Open, Classified
GKZK040026
Apr 22, 2025Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
Open, Classified
GKZK061667
Apr 22, 2025Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Open, Classified
GKZK061667
Apr 22, 2025Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Open, Classified
GKZK061667
Apr 22, 2025Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Open, Classified
GKZK061667
Apr 22, 2025Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Open, Classified
GKZK061667
Aug 16, 2024Abbott Laboratories
Alinity hq Analyzer, REF: 09P68-01
Open, Classified
GKZK220031
Jun 21, 2024SIGHT DIAGNOSTICS LTD
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Open, Classified
GKZK190898
K211840
Dec 21, 2023Abbott Laboratories
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
Open, Classified
GKZK051215
K061667
Nov 3, 2022Becton, Dickinson and Company, BD Biosciences
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute coun
Open, Classified
GKZK090967
Nov 3, 2022Becton, Dickinson and Company, BD Biosciences
BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents,
Open, Classified
GKZK090967
Nov 3, 2022Becton, Dickinson and Company, BD Biosciences
BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents,
Open, Classified
GKZK090967
Jun 14, 2022SIGHT DIAGNOSTICS LTD
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Open, Classified
GKZK190898
Jan 20, 2022SIGHT DIAGNOSTICS LTD
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red
Open, Classified
GKZK190898
Mar 17, 2021SIGHT DIAGNOSTICS LTD
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Terminated
GKZK190898
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Mar 5, 2021Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Open, Classified
GKZK102644
K162977
Jan 2, 2020Clinical Diagnostic Solutions, Inc.
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Terminated
GKZK083420
Oct 7, 2019Beckman Coulter, Inc.
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide prepara
Terminated
GKZK140911
May 23, 2019Beckman Coulter Inc.
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a memb
Terminated
GKZK140911
May 23, 2019Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop
Terminated
GKZK140911
May 23, 2019Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automate
Terminated
GKZK140911
May 9, 2019Abbott Laboratories
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Terminated
GKZK081495
Feb 20, 2019Abbott Laboratories
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
Terminated
GKZK081495

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