IS-ANTI-PR3 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-pr3 Igg Elisa Test System.

Pre-market Notification Details

Device IDK983740
510k NumberK983740
Device Name:IS-ANTI-PR3 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 Received1998-10-22
Decision Date1998-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020266 K983740 000
B3507204400 K983740 000

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