K003174 is an FDA 510(k) clearance for the ELECSYS DHEA-S. This device is classified as a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I - General Controls, product code JKC).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 17, 2001, 99 days after receiving the submission on October 10, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1245.
| 510(k) Number | K003174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2000 |
| Decision Date | January 17, 2001 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1245 |