Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System

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 Nucleic Acid Test For Use On The Cobas Liat System.

Pre-market Notification Details

Device IDK171770
510k NumberK171770
Device Name:Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System
ClassificationC. Difficile Toxin Gene Amplification Assay
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactClare Santulli
CorrespondentClare Santulli
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 Received2017-06-14
Decision Date2017-09-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.