IS-ANTI-MPO IGG ELISA TEST SYSTEM

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

COLUMBIA BIOSCIENCE, INC.

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

Pre-market Notification Details

Device IDK983390
510k NumberK983390
Device Name:IS-ANTI-MPO IGG ELISA TEST SYSTEM
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
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 CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-25
Decision Date1998-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020259 K983390 000

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