Cobas Cdiff Test

C. Difficile Toxin Gene Amplification Assay

ROCHE MOLECULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Cdiff Test.

Pre-market Notification Details

Device IDK142422
510k NumberK142422
Device Name:Cobas Cdiff Test
ClassificationC. Difficile Toxin Gene Amplification Assay
Applicant ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton,  CA  94588 -2722
ContactWilk Von Gustedt
CorrespondentDavid W. Gates
ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton,  CA  94588 -2722
Product CodeOZN  
CFR Regulation Number866.3130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-28
Decision Date2015-05-20
Summary:summary

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