Name: Predicase
Price: 199 USD

K-number	K981897
Device name	ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
Applicant	Roche Diagnostic Systems, Inc.
Product code	CJE
Device class	Class II
Decision date	Aug 26, 1998
Decision	Substantially Equivalent
Regulation	862.1050

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Source

View the full FDA submission: accessdata.fda.gov

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ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE

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