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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, Phencyclidine
510(k) Number K921651
Device Name MICROLINE SCREEN FOR PHENCYCLIDINE
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
Classification Product Code
LCM  
Date Received04/06/1992
Decision Date 07/08/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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