Cleared Traditional

Creatine Kinase

K160570 · Roche Diagnostics Operations (Rdo) · Chemistry
May 2016
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K160570 is an FDA 510(k) clearance for the Creatine Kinase, a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on May 25, 2016, 86 days after receiving the submission on February 29, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K160570 FDA.gov
FDA Decision Cleared SESE
Date Received February 29, 2016
Decision Date May 25, 2016
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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