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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
510(k) Number K190433
Device Name cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
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
Classification Product Code
QEP  
Date Received02/22/2019
Decision Date 05/22/2019
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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