K-number	K873250
Device name	ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
Applicant	Roche Diagnostic Systems, Inc.
Product code	CIJ
Device class	Class II
Decision date	Oct 20, 1987
Decision	Substantially Equivalent
Regulation	862.1070

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ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL

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