K-number	K933397
Device name	GENZYME A-AMYLASE TEST REAGENT
Applicant	Genzyme Corp.
Product code	JFJ
Device class	Class II
Decision date	Oct 28, 1993
Decision	Substantially Equivalent
Regulation	862.1070

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View the full FDA submission: accessdata.fda.gov

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GENZYME A-AMYLASE TEST REAGENT

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