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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameDADE BEHRING SYVA RAPIDTEST D.A.U.  
Document NumberK954571
Parent Document NumberK954571
Analyte NameCocaine metabolites
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date05/29/2002
Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(k) Number K954571
Device Name ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
Applicant
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Correspondent Contact JEMO KANG
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   LDJ  
Date Received10/02/1995
Decision Date 11/03/1995
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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