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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K010146
Device Name ENA EIA KIT RANGE
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 Number866.5100
Classification Product Code
LLL  
Date Received01/17/2001
Decision Date 03/01/2001
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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