ANCA COMBI DIAGNOSTIC TEST KIT

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

THE BINDING SITE, LTD.

The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Anca Combi Diagnostic Test Kit.

Pre-market Notification Details

Device IDK965133
510k NumberK965133
Device Name:ANCA COMBI DIAGNOSTIC TEST KIT
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
Applicant THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica,  CA  90404
ContactJay H Geller
CorrespondentJay H Geller
THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica,  CA  90404
Product CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-23
Decision Date1997-05-21

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