K021877 is an FDA 510(k) clearance for the MDA D-DIMER. This device is classified as a Fibrin Split Products (Class II - Special Controls, product code GHH).
Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on August 7, 2002, 61 days after receiving the submission on June 7, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K021877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2002 |
| Decision Date | August 07, 2002 |
| Days to Decision | 61 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 |