ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

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 Roche Cobas Amplicor Ct/ng Test For Neisseria Gonorrhoeae.

Pre-market Notification Details

Device IDK974342
510k NumberK974342
Device Name:ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ClassificationDna-reagents, Neisseria
Applicant ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3711
ContactAlex Wesolowski
CorrespondentAlex Wesolowski
ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3711
Product CodeLSL  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-18
Decision Date1999-05-28
Summary:summary

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