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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K902897
Device Name UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
Applicant
United Biotech, Inc.
1300c Spacepark Way
Mountain View,  CA  94043
Applicant Contact ANNJOY CHENG
Correspondent
United Biotech, Inc.
1300c Spacepark Way
Mountain View,  CA  94043
Correspondent Contact ANNJOY CHENG
Regulation Number866.5100
Classification Product Code
LRM  
Date Received07/03/1990
Decision Date 07/16/1990
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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