K905247 is an FDA 510(k) clearance for the SHBG IRMA KIT. This device is classified as a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I - General Controls, product code CDZ).
Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on January 17, 1991, 57 days after receiving the submission on November 21, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K905247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1990 |
| Decision Date | January 17, 1991 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1680 |