Cleared Traditional

ADVIA Centaur Cortisol (COR) Assy

K142723 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Mar 2015
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K142723 is an FDA 510(k) clearance for the ADVIA Centaur Cortisol (COR) Assy, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 31, 2015, 189 days after receiving the submission on September 23, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K142723 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2014
Decision Date March 31, 2015
Days to Decision 189 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