K900695 is an FDA 510(k) clearance for the ENZYMUN TEST(R) PROLACTIN. This device is classified as a Radioimmunoassay, Prolactin (lactogen) (Class I - General Controls, product code CFT).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 30, 1990, 45 days after receiving the submission on February 13, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.
| 510(k) Number | K900695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1990 |
| Decision Date | March 30, 1990 |
| Days to Decision | 45 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 |