Product code GKZ
- Device name
- Counter, Differential Cell
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5220
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | 2026-05-27 |
| K243348 | Athelas Home | Athelas, Inc. | 2026-02-06 |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 2026-01-16 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 |
| K243283 | Alinity h-series System | Abbott Laboratories | 2025-02-20 |
| K240402 | Cito CBC System | Cytochip, Inc. | 2025-02-03 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2024-07-05 |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | 2024-05-21 |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | 2024-05-02 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | 2023-12-21 |
| K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | 2023-11-14 |
| K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2023-08-16 |
| K220031 | Alinity h-series System | Abbott Laboratories | 2023-08-04 |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022-11-08 |
| K211840 | Sight OLO | S.D. Sight Diagnostics , Ltd. | 2022-05-09 |
| K200828 | Athelas Home | Athelas, Inc. | 2022-03-22 |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020-04-16 |
| K190898 | Sight OLO | Sight Diagnostics , Ltd. | 2019-11-01 |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | 2019-09-06 |
| K190294 | CELL-DYN Emerald 22 AL System | Abbott Laboratories | 2019-03-15 |
| K181475 | DxH 520 Hematology Instrument | Beckman Coulter | 2019-03-01 |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | 2019-01-25 |
| K181288 | Athelas One | Athelas, Inc. | 2018-11-05 |
| K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2018-10-29 |
| K171655 | cobas m 511 integrated hematology analyzer | Roche Diagnostics Hematology, Inc. | 2018-03-02 |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | 2017-11-06 |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | HORIBA ABX SAS | 2017-11-01 |
| K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | 2017-08-11 |
| K153538 | Dextramer CMV Kit | Immudex Aps | 2017-03-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590807696 | UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter) | Beckman Coulter, Inc. | 2026-05-19 |
| 00860008385888 | WBC Test Strip | Athelas, Inc. | 2026-04-28 |
| 00860008385871 | Athelas Home | Athelas, Inc. | 2026-04-27 |
| 00630414289694 | Atellica HEMA 580 Analyzer (SMS ready) | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 03610230009932 | ABX Micros 60 | HORIBA ABX SAS | 2026-01-23 |
| 00380740213565 | Alinity | ABBOTT LABORATORIES | 2025-12-25 |
| 00850063751216 | CitoCBC Cartridge | CYTOCHIP INC | 2025-07-01 |
| 00850063751117 | CitoCBC Analyzer | CYTOCHIP INC | 2025-07-01 |
| 06944904002422 | BC-3200 Hematology Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-01-17 |
| 04987562508440 | XQ-520 XQ-Series Automated Hematology Analyzer | SYSMEX CORPORATION | 2025-01-14 |
| 20860008385868 | Athelas Home | Athelas, Inc. | 2022-07-29 |
| 07290016991079 | HemoScreen | PIXCELL MEDICAL TECHNOLOGIES LTD | 2022-07-19 |
| 00382906641175 | BD FACSDiva | Becton, Dickinson And Company | 2020-04-08 |
| 00382906641243 | FACSCanto | Becton, Dickinson And Company | 2020-04-08 |
| 07290016991017 | HemoScreen | PIXCELL MEDICAL TECHNOLOGIES LTD | 2019-01-14 |
| 00382906624154 | BD Leucocount | Becton, Dickinson And Company | 2017-08-30 |
| 05999883586716 | ABACUS 3CP Hematology Analyzer | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag | 2016-10-06 |
| 00858092006635 | QBC Diagnostics | DRUCKER DIAGNOSTICS | 2016-09-26 |
| 00858092006222 | QBC Diagnostics | DRUCKER DIAGNOSTICS | 2016-09-24 |
| 00858092006611 | QBC Diagnostics | DRUCKER DIAGNOSTICS | 2016-09-24 |
| 10815762021456 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021586 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021562 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021531 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762021463 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 00382906595287 | BD FACSDiva | Becton, Dickinson And Company | 2016-06-08 |
| 00382906595232 | BD FACSDiva | BECTON, DICKINSON AND COMPANY | 2016-06-08 |
| 00382906579256 | BD FACSDiva™ | BECTON, DICKINSON AND COMPANY | 2016-06-08 |
| 00382906577740 | BD FACSDiva™ | BECTON, DICKINSON AND COMPANY | 2016-06-08 |
| 00382903401673 | FACSCount | Becton, Dickinson And Company | 2016-06-08 |