Cleared Traditional

Elecsys Cortisol II, Cortisol II CalSet

K152227 · Roche Diagnostics · Chemistry
Apr 2016
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K152227 is an FDA 510(k) clearance for the Elecsys Cortisol II, Cortisol II CalSet, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 27, 2016, 264 days after receiving the submission on August 7, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K152227 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2015
Decision Date April 27, 2016
Days to Decision 264 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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