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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg (Gamma Chain Specific), Antigen, Antiserum, Control
510(k) Number K021081
Device Name HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
Applicant
The Binding Site, Ltd.
West Tower, Suite 4000
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
West Tower, Suite 4000
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5510
Classification Product Code
DFZ  
Date Received04/03/2002
Decision Date 06/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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