K940005 is an FDA 510(k) clearance for the ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY. This device is classified as a Radioimmunoassay, Follicle-stimulating Hormone (Class I - General Controls, product code CGJ).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on March 3, 1994, 59 days after receiving the submission on January 3, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1300.
| 510(k) Number | K940005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1994 |
| Decision Date | March 03, 1994 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGJ — Radioimmunoassay, Follicle-stimulating Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1300 |