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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, Cannabinoids
510(k) Number K914915
Device Name MICROLINE SCREEN FOR CANNABINOID
Applicant
Drug Screening Systems, Inc.
603 Vpr Commerce Center
P.O. Box 579
Blackwood,  NJ  08012
Applicant Contact FRANCIS R PFEIFFER
Correspondent
Drug Screening Systems, Inc.
603 Vpr Commerce Center
P.O. Box 579
Blackwood,  NJ  08012
Correspondent Contact FRANCIS R PFEIFFER
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received11/04/1991
Decision Date 01/22/1992
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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