K822759 is an FDA 510(k) clearance for the ABBOTT LABORATORIES PROLACTIN EIA. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 21, 1982, 37 days after receiving the submission on September 14, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.
| 510(k) Number | K822759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1982 |
| Decision Date | October 21, 1982 |
| Days to Decision | 37 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 |