Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Roche Molecular Systems, Inc.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Tv/mg For Use On Cobas 6800/8800 Systems, Cobas Tv/mg Positive Control Kit, Cobas Buffer Negative Control Kit.

Pre-market Notification Details

Device IDK190433
510k NumberK190433
Device Name:Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactNobuko Nakajima
CorrespondentNobuko Nakajima
Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
Product CodeQEP  
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-22
Decision Date2019-05-22

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