K926322 is an FDA 510(k) clearance for the ACCESS(R) CORTISOL REAGENTS. This device is classified as a Fluorometric, Cortisol (Class II - Special Controls, product code JFT).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on May 26, 1993, 161 days after receiving the submission on December 16, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K926322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1992 |
| Decision Date | May 26, 1993 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFT — Fluorometric, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |