K041165 is an FDA 510(k) clearance for the FSH MENOPAUSE PREDICTOR TEST. This device is classified as a Radioimmunoassay, Follicle-stimulating Hormone (Class I - General Controls, product code CGJ).
Submitted by ACON Laboratories, Inc. (Beverly, US). The FDA issued a Cleared decision on June 17, 2004, 44 days after receiving the submission on May 4, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1300.
| 510(k) Number | K041165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2004 |
| Decision Date | June 17, 2004 |
| Days to Decision | 44 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 |