K833890 is an FDA 510(k) clearance for the COATEST ANTIPLASMIN. This device is classified as a Assay, Alpha-2-antiplasmin (Class II - Special Controls, product code LGP).
Submitted by Kabivitrum, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 30, 1984, 82 days after receiving the submission on November 9, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K833890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1983 |
| Decision Date | January 30, 1984 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LGP — Assay, Alpha-2-antiplasmin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |