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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Test, Tetrahydrocannabinol
510(k) Number K983147
Device Name ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
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 Number862.3870
Classification Product Code
DKE  
Subsequent Product Codes
DIO   DIS   DJG   DKN   DKZ  
LCM   LFI  
Date Received09/08/1998
Decision Date 09/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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