Cleared Traditional

Creatine Kinase-MB

K162526 · Roche Diagnostics · Chemistry
May 2017
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K162526 is an FDA 510(k) clearance for the Creatine Kinase-MB, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on May 26, 2017, 259 days after receiving the submission on September 9, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K162526 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date May 26, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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