K-number	K161527
Device name	Teco Creatinine Enzymatic Reagent Kit
Applicant	Teco Diagnostics, Inc.
Product code	JFY
Device class	Class II
Decision date	Jul 21, 2017
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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Teco Creatinine Enzymatic Reagent Kit

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