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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K012133
Device Name LIVESURE BARBITURATES 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
Correspondent Contact JAMES M BARQUEST
Regulation Number862.3150
Classification Product Code
DIS  
Date Received07/09/2001
Decision Date 07/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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