K771656 is an FDA 510(k) clearance for the PROLACTIN RIA DIAG. KIT. This device is classified as a Radioimmunoassay, Human Placental Lactogen (Class II - Special Controls, product code JMF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 22, 1977, 24 days after receiving the submission on August 29, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1585.
| 510(k) Number | K771656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1977 |
| Decision Date | September 22, 1977 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JMF — Radioimmunoassay, Human Placental Lactogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1585 |