K-number	K991597
Device name	COBAS INTEGRA AMIKACIN MAB
Applicant	Roche Diagnostics Corp.
Product code	LGJ
Device class	Class II
Decision date	Jul 22, 1999
Decision	Substantially Equivalent
Regulation	862.3035

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View the full FDA submission: accessdata.fda.gov

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COBAS INTEGRA AMIKACIN MAB

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