FDA 510(k) Applications for Medical Device Product Code "DKE"
(Reagents, Test, Tetrahydrocannabinol)

FDA 510(k) Number Applicant Device Name Decision Date
K994405 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW MARIJUANA URINE CASSETTE TEST 06/02/2000
K841831 BIOCHEMICAL DIAGNOSTIC, INC. CANNU-SKREEN-PRELIMINARY 07/06/1984
K792282 CALIFORNIA MEDICAL DEVELOPMENTS, INC. DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG 02/29/1980
K875182 MARION LABORATORIES, INC. MODIFIED LABELING FOR TOXI-LAB THC SCREEN 07/05/1988
K831456 MARION LABORATORIES, INC. TOXI-LAB CANNABINOID THC SCREEN 06/30/1983
K982211 MEDTOX DIAGNOSTICS, INC. PROFILE-II MODEL 600582 07/29/1998
K003687 MEDTOX DIAGNOSTICS, INC. VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC 12/22/2000
K983147 PRINCETON BIOMEDITECH CORP. 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 09/28/1998
K991078 PRINCETON BIOMEDITECH CORP. 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 04/15/1999
K991751 PRINCETON BIOMEDITECH CORP. STATUS CUP ACCUSIGN CUP 06/18/1999
K992068 PRINCETON BIOMEDITECH CORP. STATUS STIK, ACCUSIGN STIK 07/06/1999
K901694 TOXI-LAB, INC. SPEC(TM) EXTRACTION CARTRIDGE 06/01/1990


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