Cleared Traditional

ADVIA Centaur Cortisol (COR)

K192788 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Nov 2019
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K192788 is an FDA 510(k) clearance for the ADVIA Centaur Cortisol (COR), a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on November 25, 2019, 56 days after receiving the submission on September 30, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K192788 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2019
Decision Date November 25, 2019
Days to Decision 56 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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