K-number	K191296
Device name	Pointe Scientific Creatinine Kinase (CK) Reagent Set
Applicant	Medtest DX
Product code	CGS
Device class	Class II
Decision date	Aug 11, 2020
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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Pointe Scientific Creatinine Kinase (CK) Reagent Set

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