Cleared Traditional

SEKURE Creatine Kinase Assay

K182702 · Sekisui Diagnostics P.E.I., Inc. · Chemistry
Apr 2019
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K182702 is an FDA 510(k) clearance for the SEKURE Creatine Kinase Assay, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on April 17, 2019, 202 days after receiving the submission on September 27, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K182702 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2018
Decision Date April 17, 2019
Days to Decision 202 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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