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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, neisseria
510(k) Number K163184
Device Name cobas® CT/NG v2.0 Test
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588
Applicant Contact david w. gates
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588
Correspondent Contact david w. gates
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   OOI  
Date Received11/14/2016
Decision Date 02/09/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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