K844398 is an FDA 510(k) clearance for the COAT-A-COUNT ANDROSTENEDIONE RIA KIT. This device is classified as a Radioimmunoassay, Androstenedione (Class I — General Controls, product code CIZ).
Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 10, 1984, 27 days after receiving the submission on November 13, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1075.
| 510(k) Number | K844398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1984 |
| Decision Date | December 10, 1984 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIZ — Radioimmunoassay, Androstenedione |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1075 |