COBAS CT/NG V2.0 TEST

Dna-reagents, Neisseria

ROCHE MOLECULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Ct/ng V2.0 Test.

Pre-market Notification Details

Device IDK132270
510k NumberK132270
Device Name:COBAS CT/NG V2.0 TEST
ClassificationDna-reagents, Neisseria
Applicant ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton,  CA  94588 -2722
ContactWilk Von Gustedt
CorrespondentWilk Von Gustedt
ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton,  CA  94588 -2722
Product CodeLSL  
Subsequent Product CodeMKZ
Subsequent Product CodeOOI
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-22
Decision Date2013-12-02
Summary:summary

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