K-number	K971566
Device name	CREATINE KINASE-MB REAGENT SET
Applicant	Horizon Diagnostics, Inc.
Product code	CGS
Device class	Class II
Decision date	Jul 14, 1997
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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CREATINE KINASE-MB REAGENT SET

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