FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT

Anti-dna Antibody (enzyme-labeled), Antigen, Control

THE BINDING SITE, LTD.

The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Farrzyme Human High Avidity Anti-dsdna Enzyme Immunoassay Kit.

Pre-market Notification Details

Device IDK062183
510k NumberK062183
Device Name:FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
ClassificationAnti-dna Antibody (enzyme-labeled), Antigen, Control
Applicant THE BINDING SITE, LTD. 2425 W. OLYMPIC BLV Santa Monica,  CA  90404
ContactJay H Geller
CorrespondentJay H Geller
THE BINDING SITE, LTD. 2425 W. OLYMPIC BLV Santa Monica,  CA  90404
Product CodeLRM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-31
Decision Date2006-11-21
Summary:summary

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