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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
510(k) Number K011011
Device Name LIVESURE MORPHINE SCREEN TEST
Applicant
Pan Probe Biotech, Inc.
8515 Arjons Dr., Suite A
San Diego,  CA  92126
Applicant Contact ALICE H YU
Correspondent
California Department of Health Services
P.O. Box 942732 (Ms-357)
Sacramento,  CA  94234
Regulation Number862.3640
Classification Product Code
DOE  
Date Received04/04/2001
Decision Date 04/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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