K913280 is an FDA 510(k) clearance for the OPUS(R) PROLACTIN TEST SYSTEM. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on August 16, 1991, 23 days after receiving the submission on July 24, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1625.
| 510(k) Number | K913280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1991 |
| Decision Date | August 16, 1991 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | CFT — Radioimmunoassay, Prolactin (lactogen) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1625 |