K802195 is an FDA 510(k) clearance for the DEHYDROEPIANDROSTERONE SULFATE KIT RIA. This device is classified as a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I - General Controls, product code JKC).
Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 43 days after receiving the submission on September 10, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1245.
| 510(k) Number | K802195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 43 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 |