COBAS 4800 CT / NG TEST

Dna Probe, Nucleic Acid Amplification, Chlamydia

ROCHE MOLECULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas 4800 Ct / Ng Test.

Pre-market Notification Details

Device IDK110923
510k NumberK110923
Device Name:COBAS 4800 CT / NG TEST
ClassificationDna Probe, Nucleic Acid Amplification, Chlamydia
Applicant ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton,  CA  94588 -2722
ContactJames Bonds
CorrespondentJames Bonds
ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton,  CA  94588 -2722
Product CodeMKZ  
Subsequent Product CodeLSL
Subsequent Product CodeOOI
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-01
Decision Date2012-01-24
Summary:summary

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