K791740 is an FDA 510(k) clearance for the SERUM 11-DESOXYCORTISOL I AS TRACER. This device is classified as a Radioimmunoassay, Compound S (11-deoxycortisol) (Class I - General Controls, product code JKB).
Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979, 17 days after receiving the submission on September 10, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1185.
| 510(k) Number | K791740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1979 |
| Decision Date | September 27, 1979 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JKB — Radioimmunoassay, Compound S (11-deoxycortisol) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1185 |