CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT

Ceruloplasmin, Antigen, Antiserum, Control

THE BINDING SITE, LTD.

The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Caeruloplasmin Immunological Nl Test Kit.

Pre-market Notification Details

Device IDK913668
510k NumberK913668
Device Name:CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
ClassificationCeruloplasmin, Antigen, Antiserum, Control
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 CodeDDB  
CFR Regulation Number866.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-19
Decision Date1991-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051700010719 K913668 000

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