GKZ — Counter, Differential Cell Class II
FDA product code GKZ covers "Counter, Differential Cell", a Class II medical device regulated under 21 CFR 864.5220. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKZ
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260781 | Horiba Abx | Yumizen H550 | Sep 14, 2026 |
| K253212 | Sysmex America | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | May 27, 2026 |
| K243348 | Athelas | Athelas Home | Feb 6, 2026 |
| K251249 | Truvian Sciences | Tru Hematology Test | Jan 16, 2026 |
| K250943 | Sysmex America | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Jun 25, 2025 |
| K251371 | Sysmex America | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Jun 25, 2025 |
| K243283 | Abbott Laboratories | Alinity h-series System | Feb 20, 2025 |
| K240402 | Cytochip | Cito CBC System | Feb 3, 2025 |
| K240252 | Beckman Coulter | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer I | Jul 5, 2024 |
| K232946 | Horiba Abx | Yumizen H2500 | May 21, 2024 |
| K240636 | Pixcell Medical Technologies | HemoScreen Hematology Analyzer | May 2, 2024 |
| K230887 | Sysmex America | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Dec 21, 2023 |
| K230878 | Ad Astra Diagnostics | QScout Lab; QScout RLD | Nov 14, 2023 |
| K222148 | Pixcell Medical Technologies | HemoScreen Hematology Analyzer | Aug 16, 2023 |
| K220031 | Abbott Laboratories | Alinity h-series System | Aug 4, 2023 |
| K210346 | Sysmex America | Sysmex XW-100 Automated Hematology Analyzer | Nov 8, 2022 |
| K211840 | S.D. Sight Diagnostics | Sight OLO | May 9, 2022 |
| K200828 | Athelas | Athelas Home | Mar 22, 2022 |
| K193124 | Beckman Coulter | Unicel DxH 800 Coulter Cellular Analysis System | Apr 16, 2020 |
| K190898 | Sight Diagnostics | Sight OLO | Nov 1, 2019 |