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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, Barbiturate
510(k) Number K933480
Device Name MICROLINE SCREEN FOR BARBITURATES
Applicant
Drug Screening Systems, Inc.
P.O. Box 579
Blackwood,  NJ  08012
Applicant Contact KENNETH S CARPENTER
Correspondent
Drug Screening Systems, Inc.
P.O. Box 579
Blackwood,  NJ  08012
Correspondent Contact KENNETH S CARPENTER
Regulation Number862.3150
Classification Product Code
DIS  
Date Received07/15/1993
Decision Date 10/29/1993
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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