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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K864142
Device Name UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
Applicant
United Biotech, Inc.
1300c Spacepark Way
Mountain View,  CA  94043
Applicant Contact JOSEPH FU
Correspondent
United Biotech, Inc.
1300c Spacepark Way
Mountain View,  CA  94043
Correspondent Contact JOSEPH FU
Regulation Number866.5510
Classification Product Code
DGC  
Date Received10/22/1986
Decision Date 12/03/1986
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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