K-number	K964670
Device name	ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
Applicant	Roche Diagnostic Systems, Inc.
Product code	LFW
Device class	Class II
Decision date	Feb 4, 1997
Decision	Substantially Equivalent
Regulation	862.3900

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ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

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