Cleared Traditional

ELECSYS CORTISOL TEST SYSTEM

K021218 · Roche Diagnostics Corp. · Chemistry
Sep 2002
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K021218 is an FDA 510(k) clearance for the ELECSYS CORTISOL TEST SYSTEM, 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 review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K021218 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JFT — Fluorometric, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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