K940221 is an FDA 510(k) clearance for the ACCESS CORTISOL REAGENTS. This device is classified as a Radioimmunoassay, Cortisol (Class II - Special Controls, product code CGR).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on April 26, 1994, 98 days after receiving the submission on January 18, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K940221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1994 |
| Decision Date | April 26, 1994 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |