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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K905473
Device Name UBI MAGIWEL CORTISOL QUANTITATIVE
Applicant
United Biotech, Inc.
1300c Spacepark Way
Mountain View,  CA  94043
Applicant Contact SUN
Correspondent
United Biotech, Inc.
1300c Spacepark Way
Mountain View,  CA  94043
Correspondent Contact SUN
Regulation Number862.1205
Classification Product Code
CGR  
Date Received12/06/1990
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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