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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K883399
Device Name UBI MAGIWEL CMV IGG 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 Number866.3175
Classification Product Code
LFZ  
Date Received08/11/1988
Decision Date 03/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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