K802840 is an FDA 510(k) clearance for the ALPHA-ANTIPLASM ASSAY. This device is classified as a Assay, Alpha-2-antiplasmin (Class II - Special Controls, product code LGP).
Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on February 17, 1981, 97 days after receiving the submission on November 12, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K802840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1980 |
| Decision Date | February 17, 1981 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LGP — Assay, Alpha-2-antiplasmin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |