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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, Amphetamine
510(k) Number K971109
Device Name QUIKPAC II ONE STEP AMPHETAMINE TEST
Applicant
Drial Consultants, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Applicant Contact CLEVE W LAIRD
Correspondent
Drial Consultants, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Correspondent Contact CLEVE W LAIRD
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received03/26/1997
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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