K-number	K990594
Device name	INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
Applicant	Roche Diagnostics Corp.
Product code	DER
Device class	Class II
Decision date	Apr 14, 1999
Decision	Substantially Equivalent
Regulation	866.5580

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View the full FDA submission: accessdata.fda.gov

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INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1

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