K222148 is an FDA 510(k) clearance for the HemoScreen Hematology Analyzer. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Pixcell Medical Technologies, Ltd. (Yoknaem Ilit, IL). The FDA issued a Cleared decision on August 16, 2023, 392 days after receiving the submission on July 20, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K222148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2022 |
| Decision Date | August 16, 2023 |
| Days to Decision | 392 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 |