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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 K173887
Device Name cobas CT/NG for use on cobas 6800/8800 systems
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Applicant Contact nobuko nakajima
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Correspondent Contact nobuko nakajima
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   OOI  
Date Received12/21/2017
Decision Date 03/21/2018
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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