K243283 is an FDA 510(k) clearance for the Alinity h-series System. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on February 20, 2025, 126 days after receiving the submission on October 17, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K243283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2024 |
| Decision Date | February 20, 2025 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |