K092868 is an FDA 510(k) clearance for the CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by CellaVision AB (Fridley, US). The FDA issued a Cleared decision on November 20, 2009, 63 days after receiving the submission on September 18, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K092868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2009 |
| Decision Date | November 20, 2009 |
| Days to Decision | 63 days |
| Submission Type | Special |
| 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 |