K812829 is an FDA 510(k) clearance for the COATEST ANTITHROMBIN. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Kabivitrum, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1981, 83 days after receiving the submission on October 8, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K812829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1981 |
| Decision Date | December 30, 1981 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |