K-number	K141265
Device name	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Applicant	Elitechgroup
Product code	JHW
Device class	Class II
Decision date	Jul 18, 2014
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

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