K-number	K012287
Device name	MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
Applicant	Roche Diagnostics Corp.
Product code	MRR
Device class	Class I
Decision date	Aug 7, 2001
Decision	Substantially Equivalent
Regulation	862.1475

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MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

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