K061683 is an FDA 510(k) clearance for the TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 21, 2006, 36 days after receiving the submission on June 15, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K061683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2006 |
| Decision Date | July 21, 2006 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5680 |