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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 K991078
Device Name ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
Applicant
Princeton BioMeditech Corp.
4242 U.S. Route 1
P.O. Box 7139
Monmouth Junction,  NJ  08852 -1905
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Route 1
P.O. Box 7139
Monmouth Junction,  NJ  08852 -1905
Correspondent Contact JEMO KANG
Regulation Number862.3870
Classification Product Code
DKE  
Subsequent Product Codes
DIO   DIS   DJG   DKN   DKZ  
LCM   LFI  
Date Received03/26/1999
Decision Date 04/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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