Cleared Traditional

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

K160724 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Sep 2016
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K160724 is an FDA 510(k) clearance for the ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on September 7, 2016, 175 days after receiving the submission on March 16, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K160724 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2016
Decision Date September 07, 2016
Days to Decision 175 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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