IS H. PYLORI IGG ELISA TEST SYSTEM

Helicobacter Pylori

COLUMBIA BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Columbia Bioscience, Inc. with the FDA for Is H. Pylori Igg Elisa Test System.

Pre-market Notification Details

Device IDK990462
510k NumberK990462
Device Name:IS H. PYLORI IGG ELISA TEST SYSTEM
ClassificationHelicobacter Pylori
Applicant COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia,  MD  21045
ContactNorman Jenkins
CorrespondentNorman Jenkins
COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia,  MD  21045
Product CodeLYR  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-12
Decision Date1999-09-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020037 K990462 000

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