K021218 is an FDA 510(k) clearance for the ELECSYS CORTISOL TEST SYSTEM. This device is classified as a Fluorometric, Cortisol (Class II - Special Controls, product code JFT).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 9, 2002, 145 days after receiving the submission on April 17, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K021218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2002 |
| Decision Date | September 09, 2002 |
| Days to Decision | 145 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 |