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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Systemic Lupus Erythematosus
510(k) Number K930247
Device Name HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
Applicant
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number866.5820
Classification Product Code
DHC  
Date Received01/19/1993
Decision Date 03/10/1993
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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