K181475 is an FDA 510(k) clearance for the DxH 520 Hematology Instrument. 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 March 1, 2019, 270 days after receiving the submission on June 4, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K181475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | June 04, 2018 |
| Decision Date | March 01, 2019 |
| Days to Decision | 270 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 |