Home / Device Classification / DKE

DKE — Reagents, Test, Tetrahydrocannabinol Class II

FDA Device Classification

Classification Details

Product Code
DKE
Device Class
Class II
Regulation Number
862.3870
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K003687medtox diagnosticsVERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICTDecember 22, 2000
K994405alfa scientific designsINSTANT-VIEW MARIJUANA URINE CASSETTE TESTJune 2, 2000
K992068princeton biomeditechSTATUS STIK, ACCUSIGN STIKJuly 6, 1999
K991751princeton biomeditechSTATUS CUP ACCUSIGN CUPJune 18, 1999
K991078princeton biomeditechACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPApril 15, 1999
K983147princeton biomeditechACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, September 28, 1998
K982211medtox diagnosticsPROFILE-II MODEL 600582July 29, 1998
K901694toxi-labSPEC(TM) EXTRACTION CARTRIDGEJune 1, 1990
K875182marion laboratoriesMODIFIED LABELING FOR TOXI-LAB THC SCREENJuly 5, 1988
K841831biochemical diagnosticCANNU-SKREEN-PRELIMINARYJuly 6, 1984
K831456marion laboratoriesTOXI-LAB CANNABINOID THC SCREENJune 30, 1983
K792282california medical developmentsDRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUGFebruary 29, 1980