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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K924689
Device Name UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
Applicant
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041
Applicant Contact JOSEPH FU
Correspondent
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041
Correspondent Contact JOSEPH FU
Regulation Number866.3110
Classification Product Code
LYR  
Date Received09/17/1992
Decision Date 08/10/1993
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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