K942051 is an FDA 510(k) clearance for the SR1 DHEA-S ENZYME IMMUNOASSAY. This device is classified as a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I — General Controls, product code JKC).
Submitted by Serono Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on July 13, 1994, 76 days after receiving the submission on April 28, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1245.
| 510(k) Number | K942051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1994 |
| Decision Date | July 13, 1994 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1245 |