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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ceruloplasmin, Antigen, Antiserum, Control
510(k) Number K913668
Device Name CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
Applicant
THE BINDING SITE, LTD.
WESTSIDE TOWERS, SUITE 1000
11845 WEST OLYMPIC BLVD.
LOS ANGELES,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
THE BINDING SITE, LTD.
WESTSIDE TOWERS, SUITE 1000
11845 WEST OLYMPIC BLVD.
LOS ANGELES,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number866.5210
Classification Product Code
DDB  
Date Received08/19/1991
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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