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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 K935052
Device Name MICROLINE SCREEN FOR AMPHETAMINE
Applicant
Drug Screening Systems, Inc.
603 Vpr Commerce Center
P.O. Box 579
Blackwood,  NJ  08012
Applicant Contact KENNETH S CARPENTER
Correspondent
Drug Screening Systems, Inc.
603 Vpr Commerce Center
P.O. Box 579
Blackwood,  NJ  08012
Correspondent Contact KENNETH S CARPENTER
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received10/20/1993
Decision Date 09/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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