K872862 is an FDA 510(k) clearance for the PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).
Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on September 18, 1987, 59 days after receiving the submission on July 21, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.
| 510(k) Number | K872862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1987 |
| Decision Date | September 18, 1987 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFT — Radioimmunoassay, Prolactin (lactogen) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1625 |