K895421 is an FDA 510(k) clearance for the CORTISOL TEST SYSTEM. This device is classified as a Fluorometric, Cortisol (Class II - Special Controls, product code JFT).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on December 7, 1989, 97 days after receiving the submission on September 1, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K895421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1989 |
| Decision Date | December 07, 1989 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFT — Fluorometric, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |