K992365 is an FDA 510(k) clearance for the AIA-PACK FOLATE ASSAY. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on August 10, 1999, 26 days after receiving the submission on July 15, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K992365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1999 |
| Decision Date | August 10, 1999 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |