K120771 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, Inc. (Miami, US). The FDA issued a Cleared decision on March 22, 2013, 373 days after receiving the submission on March 14, 2012.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K120771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2012 |
| Decision Date | March 22, 2013 |
| Days to Decision | 373 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 |