K040181 is an FDA 510(k) clearance for the ACCESS DHEA-S REAGENT ASSAY. This device is classified as a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I - General Controls, product code JKC).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 24, 2004, 57 days after receiving the submission on January 27, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1245.
| 510(k) Number | K040181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2004 |
| Decision Date | March 24, 2004 |
| Days to Decision | 57 days |
| Submission Type | Abbreviated |
| 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 |