K-number	K070064
Device name	AMYLASE EPS REAGENT
Applicant	Thermo Fisher Scientific
Product code	JFJ
Device class	Class II
Decision date	May 22, 2007
Decision	Substantially Equivalent
Regulation	862.1070

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Source

View the full FDA submission: accessdata.fda.gov

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AMYLASE EPS REAGENT

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