K821611 is an FDA 510(k) clearance for the GAMMADAB [125] FSH RADIOIMMUNAY KIT. This device is classified as a Radioimmunoassay, Follicle-stimulating Hormone (Class I - General Controls, product code CGJ).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982, 22 days after receiving the submission on June 2, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1300.
| 510(k) Number | K821611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1982 |
| Decision Date | June 24, 1982 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGJ — Radioimmunoassay, Follicle-stimulating Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1300 |