K200595 is an FDA 510(k) clearance for the CellaVision DC-1, CellaVision DC-1 PPA. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by CellaVision AB (Lund, SE). The FDA issued a Cleared decision on October 16, 2020, 224 days after receiving the submission on March 6, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K200595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2020 |
| Decision Date | October 16, 2020 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOY - Device, Automated Cell-locating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5260 |