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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 K945609
Device Name ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
Applicant
Princeton BioMeditech Corp.
P.O. Box 7139
Princeton,  NJ  08543
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
P.O. Box 7139
Princeton,  NJ  08543
Correspondent Contact JEMO KANG
Regulation Number862.3250
Classification Product Code
DIO  
Date Received11/15/1994
Decision Date 02/22/1995
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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