Creatine Kinase-MB— 510(k) K162526

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K162526 for Creatine Kinase-MB, Substantially Equivalent on 2017-05-26. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2016-09-09
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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