K062203 is an FDA 510(k) clearance for the TINA-QUANT D-DIMER TEST SYSTEM. This device is classified as a Fibrin Split Products (Class II - Special Controls, product code GHH).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 14, 2007, 225 days after receiving the submission on August 1, 2006.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K062203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2006 |
| Decision Date | March 14, 2007 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GHH — Fibrin Split Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7320 |