K-number	K160570
Device name	Creatine Kinase
Applicant	Roche Diagnostics Operations (Rdo)
Product code	JHS
Device class	Class II
Decision date	May 25, 2016
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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Creatine Kinase

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