K864213 is an FDA 510(k) clearance for the IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY. This device is classified as a Assay, Alpha-2-antiplasmin (Class II - Special Controls, product code LGP).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 25, 1986, 28 days after receiving the submission on October 28, 1986.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K864213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1986 |
| Decision Date | November 25, 1986 |
| Days to Decision | 28 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 |