K962118 is an FDA 510(k) clearance for the DSL ACTIVE FSH IRMA. This device is classified as a Radioimmunoassay, Follicle-stimulating Hormone (Class I - General Controls, product code CGJ).
Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on September 9, 1996, 101 days after receiving the submission on May 31, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1300.
| 510(k) Number | K962118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1996 |
| Decision Date | September 09, 1996 |
| Days to Decision | 101 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 |