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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase (Prostatic), Tartrate Inhibited
510(k) Number K981573
Device Name UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
Applicant
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041
Applicant Contact SHARON SUN
Correspondent
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041
Correspondent Contact SHARON SUN
Regulation Number862.1020
Classification Product Code
JFH  
Date Received05/04/1998
Decision Date 09/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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