K-number	K860935
Device name	EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
Applicant	Em Diagnostic Systems, Inc.
Product code	CIJ
Device class	Class II
Decision date	May 23, 1986
Decision	Substantially Equivalent
Regulation	862.1070

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EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95

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