K182886 is an FDA 510(k) clearance for the Cytomics FC 500 Series (MPL or MCL) Flow Cytometer. 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 September 6, 2019, 326 days after receiving the submission on October 15, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K182886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2018 |
| Decision Date | September 06, 2019 |
| Days to Decision | 326 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | GKZ - Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |