Curian HpSA, Curian Analyzer

Helicobacter Pylori

Meridian Bioscience, Inc.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Curian Hpsa, Curian Analyzer.

Pre-market Notification Details

Device IDK192817
510k NumberK192817
Device Name:Curian HpSA, Curian Analyzer
ClassificationHelicobacter Pylori
Applicant Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati,  OH  45244
ContactCathlena Martinez
CorrespondentCathlena Martinez
Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati,  OH  45244
Product CodeLYR  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-03-13

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.