K901673 is an FDA 510(k) clearance for the PROLACTIN (LACTOGEN) TEST SYSTEM. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on June 12, 1990, 63 days after receiving the submission on April 10, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.
| 510(k) Number | K901673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1990 |
| Decision Date | June 12, 1990 |
| Days to Decision | 63 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 |