K-number	K913858
Device name	AMYLASE REAGENT (PROCEDURE 577)
Applicant	Sigma Diagnostics, Inc.
Product code	JFJ
Device class	Class II
Decision date	Sep 11, 1991
Decision	Substantially Equivalent
Regulation	862.1070

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View the full FDA submission: accessdata.fda.gov

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AMYLASE REAGENT (PROCEDURE 577)

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