K-number	K061048
Device name	COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
Applicant	Roche Diagnostics Corp.
Product code	CFR
Device class	Class II
Decision date	May 17, 2006
Decision	Substantially Equivalent
Regulation	862.1345

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View the full FDA submission: accessdata.fda.gov

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COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

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