K-number	K123726
Device name	COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
Applicant	Roche Diagnostics
Product code	JGS
Device class	Class II
Decision date	May 21, 2013
Decision	Substantially Equivalent
Regulation	862.1665

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View the full FDA submission: accessdata.fda.gov

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COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

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