K842555 is an FDA 510(k) clearance for the DHEA-S DIRECT RIA KIT. This device is classified as a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I - General Controls, product code JKC).
Submitted by Biotecx Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on August 7, 1984, 36 days after receiving the submission on July 2, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1245.
| 510(k) Number | K842555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1984 |
| Decision Date | August 07, 1984 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1245 |