K080595 is an FDA 510(k) clearance for the CELLAVISION DM96 WITH THE BODY FLUID APPLICATION. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by CellaVision AB (Minneapolis,, US). The FDA issued a Cleared decision on December 5, 2008, 277 days after receiving the submission on March 3, 2008.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K080595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2008 |
| Decision Date | December 05, 2008 |
| Days to Decision | 277 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 |