K-number	K100853
Device name	COBAS 8000 MODULAR SERIES ANALYZER
Applicant	Roche Diagnostics Corp.
Product code	DCF
Device class	Class II
Decision date	Sep 9, 2010
Decision	Substantially Equivalent
Regulation	866.5040

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Source

View the full FDA submission: accessdata.fda.gov

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COBAS 8000 MODULAR SERIES ANALYZER

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