K-number	K973718
Device name	ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Applicant	Roche Molecular Systems, Inc.
Product code	MKZ
Device class	Class I
Decision date	Dec 15, 1998
Decision	Substantially Equivalent
Regulation	866.3120

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ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

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