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) |
|---|---|---|---|
| Nov 12, 2025 | Abbott 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 |
GKZ | K220031 K243283 |
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF:B23858 Open, Classified |
GKZ | K120771 |
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REFs:B24802, 629029, B63322 Open, Classified |
GKZ | K193124 |
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C34520 Open, Classified |
GKZ | K240252 |
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C11478 Open, Classified |
GKZ | K240252 |
| Aug 1, 2025 | Becton, Dickinson and Company, BD Bio Sciences BD Trucount Controls, 30 Test - REF: 340335 Open, Classified |
GKZ | None listed |
| Aug 1, 2025 | Becton, Dickinson and Company, BD Bio Sciences BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD Open, Classified |
GKZ | None listed |
| Jul 3, 2025 | Becton, 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 |
GKZ | K040026 |
| Jul 3, 2025 | Becton, 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 |
GKZ | K040026 |
| Apr 22, 2025 | Abbott 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 |
GKZ | K061667 |
| Apr 22, 2025 | Abbott 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 |
GKZ | K061667 |
| Apr 22, 2025 | Abbott 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 |
GKZ | K061667 |
| Apr 22, 2025 | Abbott 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 |
GKZ | K061667 |
| Apr 22, 2025 | Abbott 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 |
GKZ | K061667 |
| Aug 16, 2024 | Abbott Laboratories Alinity hq Analyzer, REF: 09P68-01 Open, Classified |
GKZ | K220031 |
| Jun 21, 2024 | SIGHT 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 |
GKZ | K190898 K211840 |
| Dec 21, 2023 | Abbott 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 |
GKZ | K051215 K061667 |
| Nov 3, 2022 | Becton, 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 |
GKZ | K090967 |
| Nov 3, 2022 | Becton, 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 |
GKZ | K090967 |
| Nov 3, 2022 | Becton, 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 |
GKZ | K090967 |
| Jun 14, 2022 | SIGHT DIAGNOSTICS LTD Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 Open, Classified |
GKZ | K190898 |
| Jan 20, 2022 | SIGHT 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 |
GKZ | K190898 |
| Mar 17, 2021 | SIGHT 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 |
GKZ | K190898 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens 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 |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens 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 |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens 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 |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens 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 |
GKZ | K102644 K162977 |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | K102644 K162977 |
| Jan 2, 2020 | Clinical Diagnostic Solutions, Inc. Medonic M-Series Hematology Analyzer
M16S BD ABR US
Product code: 1400075;
OUS Product code 1400011 Terminated |
GKZ | K083420 |
| Oct 7, 2019 | Beckman 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 |
GKZ | K140911 |
| May 23, 2019 | Beckman 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 |
GKZ | K140911 |
| May 23, 2019 | Beckman 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 |
GKZ | K140911 |
| May 23, 2019 | Beckman 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 |
GKZ | K140911 |
| May 9, 2019 | Abbott 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 |
GKZ | K081495 |
| Feb 20, 2019 | Abbott 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 |
GKZ | K081495 |
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