K240636 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 (Yokneam Ilit, IL). The FDA issued a Cleared decision on May 2, 2024, 57 days after receiving the submission on March 6, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K240636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2024 |
| Decision Date | May 02, 2024 |
| Days to Decision | 57 days |
| Submission Type | Abbreviated |
| 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 |