K193124 is an FDA 510(k) clearance for the Unicel DxH 800 Coulter Cellular Analysis System. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on April 16, 2020, 156 days after receiving the submission on November 12, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K193124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | April 16, 2020 |
| Days to Decision | 156 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 |