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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, Cocaine And Cocaine Metabolites
510(k) Number K962353
Device Name ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
Applicant
Princeton BioMeditech Corp.
P.O. Box 7139
Princeton,  NJ  08543
Applicant Contact JEMO KANG, PH.D.
Correspondent
Princeton BioMeditech Corp.
P.O. Box 7139
Princeton,  NJ  08543
Correspondent Contact JEMO KANG, PH.D.
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DNI   LCM  
Date Received06/18/1996
Decision Date 08/19/1996
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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