K011143 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 May 29, 2001, 46 days after receiving the submission on April 13, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K011143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2001 |
| Decision Date | May 29, 2001 |
| Days to Decision | 46 days |
| Submission Type | Special |
| 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 |