K913938 is an FDA 510(k) clearance for the OPUS(R) LH TEST SYSTEM. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on November 7, 1991, 65 days after receiving the submission on September 3, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K913938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1991 |
| Decision Date | November 07, 1991 |
| Days to Decision | 65 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 |