K-number	K163184
Device name	cobas® CT/NG v2.0 Test
Applicant	Roche Molecular Systems, Inc.
Product code	LSL
Device class	Class II
Decision date	Feb 9, 2017
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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cobas® CT/NG v2.0 Test

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