IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC

Immunoelectrophoretic, Immunoglobulins, (g, A, M)

THE BINDING SITE, LTD.

The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Immunoglobulins G, A & M And Light Chain Specific.

Pre-market Notification Details

Device IDK924769
510k NumberK924769
Device Name:IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
ClassificationImmunoelectrophoretic, Immunoglobulins, (g, A, M)
Applicant THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles,  CA  90064
ContactJay H Geller
CorrespondentJay H Geller
THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles,  CA  90064
Product CodeCFF  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-23
Decision Date1993-02-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051700011211 K924769 000

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