DKE · Class II · 21 CFR 862.3870

FDA Product Code DKE: Reagents, Test, Tetrahydrocannabinol

Leading manufacturers include Princeton BioMeditech Corp., Medtox Diagnostics, Inc. and Marion Laboratories, Inc..

12
Total
12
Cleared
65d
Avg days
1980
Since

FDA 510(k) Cleared Reagents, Test, Tetrahydrocannabinol Devices (Product Code DKE)

12 devices
1–12 of 12
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
K003687
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Jun 02, 2000
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
K994405
Alfa Scientific Designs, Inc.
Toxicology · 157d
Cleared Jul 06, 1999
STATUS STIK, ACCUSIGN STIK
K992068
Princeton BioMeditech Corp.
Toxicology · 18d
Cleared Jun 18, 1999
STATUS CUP ACCUSIGN CUP
K991751
Princeton BioMeditech Corp.
Toxicology · 25d
Cleared Apr 15, 1999
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
K991078
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Sep 28, 1998
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
K983147
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Jul 29, 1998
PROFILE-II MODEL 600582
K982211
Medtox Diagnostics, Inc.
Toxicology · 36d
Cleared Jun 01, 1990
SPEC(TM) EXTRACTION CARTRIDGE
K901694
Toxi-Lab, Inc.
Toxicology · 52d
Cleared Jul 05, 1988
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182
Marion Laboratories, Inc.
Toxicology · 201d
Cleared Jul 06, 1984
CANNU-SKREEN-PRELIMINARY
K841831
Biochemical Diagnostic, Inc.
Toxicology · 64d
Cleared Jun 30, 1983
TOXI-LAB CANNABINOID THC SCREEN
K831456
Marion Laboratories, Inc.
Toxicology · 55d
Cleared Feb 29, 1980
DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG
K792282
California Medical Developments, Inc.
Toxicology · 108d

About Product Code DKE - Regulatory Context