K-number	K140373
Device name	ISE INDIRECT NA, K, C1 FOR GEN 2
Applicant	Roche Diagnostics
Product code	JGS
Device class	Class II
Decision date	May 22, 2014
Decision	Substantially Equivalent
Regulation	862.1665

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View the full FDA submission: accessdata.fda.gov

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ISE INDIRECT NA, K, C1 FOR GEN 2

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