GKZ
- Product code
- GKZ
- Device name
- Counter, Differential Cell
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5220
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 12 (direct download)
- 510(k) clearances (all years, FDA)
- 380 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253212 | 2026-05-27 | Sysmex America, Inc. | XR-Series (XR-10, XR-20) Automated Hematology Analyz… | |
| K243348 | 2026-02-06 | Athelas, Inc. | Athelas Home | |
| K251249 | 2026-01-16 | Truvian Sciences, Inc. | Tru Hematology Test | |
| K251371 | 2025-06-25 | Sysmex America, Inc. | Sysmex XR-Series (XR-20) Automated Hematology Analyz… | |
| K250943 | 2025-06-25 | Sysmex America, Inc. | Sysmex XR-Series (XR-10) Automated Hematology Analyz… | |
| K243283 | 2025-02-20 | Abbott Laboratories | Alinity h-series System | |
| K240402 | 2025-02-03 | Cytochip, Inc. | Cito CBC System | |
| K240252 | 2024-07-05 | Beckman Coulter, Inc. | UniCel DxH 900 Coulter Cellular Analysis System; Uni… | |
| K232946 | 2024-05-21 | HORIBA ABX SAS | Yumizen H2500 | |
| K240636 | 2024-05-02 | Pixcell Medical Technologies | HemoScreen Hematology Analyzer | |
| K230887 | 2023-12-21 | Sysmex America, Inc. | Sysmex XQ-Series (XQ-320) Automated Hematology Analy… | |
| K230878 | 2023-11-14 | Ad Astra Diagnostics, Inc. | QScout Lab; QScout RLD |
Official FDA classification page: GKZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).