K954755 is an FDA 510(k) clearance for the COAT-A-COUNT DIRECT ANDROSTENEDIONE. 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 November 29, 1995, 44 days after receiving the submission on October 16, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1075.
| 510(k) Number | K954755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1995 |
| Decision Date | November 29, 1995 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIZ — Radioimmunoassay, Androstenedione |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1075 |