K162414 is an FDA 510(k) clearance for the UniCel DxH SlideMaker Stainer 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 November 29, 2016, 92 days after receiving the submission on August 29, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K162414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2016 |
| Decision Date | November 29, 2016 |
| Days to Decision | 92 days |
| Submission Type | Special |
| 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 |