K832452 is an FDA 510(k) clearance for the ANDROSTENEDIONE TEST SET 125I. This device is classified as a Radioimmunoassay, Androstenedione (Class I - General Controls, product code CIZ).
Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 49 days after receiving the submission on July 25, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1075.
| 510(k) Number | K832452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 49 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 |