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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, Rheumatoid Factor
510(k) Number K883355
Device Name UBI MAGIWEL RF-IGM QUANTITATIVE
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 Number866.5775
Classification Product Code
DHR  
Date Received08/09/1988
Decision Date 09/07/1988
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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