K963693 is an FDA 510(k) clearance for the OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on November 29, 1996, 74 days after receiving the submission on September 16, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K963693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1996 |
| Decision Date | November 29, 1996 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1485 |