K-number	K070172
Device name	AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Applicant	Roche Diagnostics Corporation
Product code	LSL
Device class	Class II
Decision date	Apr 17, 2007
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

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