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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, Cocaine And Cocaine Metabolites
510(k) Number K992990
Device Name QUICKPAC II ONE STEP COCAINE TEST
Applicant
Syntron Bioresearch, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Applicant Contact CLEVE W LAIRD
Correspondent
California Department of Health Services
P.O. Box 942732 (Ms-357)
Sacramento,  CA  94234
Regulation Number862.3250
Classification Product Code
DIO  
Date Received09/07/1999
Decision Date 09/20/1999
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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