K900485 is an FDA 510(k) clearance for the ENZYMUN TEST(R) CORTISOL. This device is classified as a Radioimmunoassay, Cortisol (Class II - Special Controls, product code CGR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 2, 1990, 90 days after receiving the submission on February 1, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K900485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1990 |
| Decision Date | May 02, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |