Atlas FDA

DKE

12 FDA 510(k) clearances · Product code

52 daysmedian time to decision
157 days90th percentile
12clearances measured

FDA profile

Official device name
Reagents, Test, Tetrahydrocannabinol
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
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.2000-12-22
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST (K994405)Alfa Scientific Designs, Inc.2000-06-02
STATUS STIK, ACCUSIGN STIK (K992068)Princeton BioMeditech Corp.1999-07-06
STATUS CUP ACCUSIGN CUP (K991751)Princeton BioMeditech Corp.1999-06-18
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.1999-04-15
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.1998-09-28
PROFILE-II MODEL 600582 (K982211)Medtox Diagnostics, Inc.1998-07-29
SPEC(TM) EXTRACTION CARTRIDGE (K901694)Toxi-Lab, Inc.1990-06-01
MODIFIED LABELING FOR TOXI-LAB THC SCREEN (K875182)Marion Laboratories, Inc.1988-07-05
CANNU-SKREEN-PRELIMINARY (K841831)Biochemical Diagnostic, Inc.1984-07-06
TOXI-LAB CANNABINOID THC SCREEN (K831456)Marion Laboratories, Inc.1983-06-30
DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG (K792282)California Medical Developments, Inc.1980-02-29

Track DKE automatically

Every clearance here is in the API, with alerts when new ones post.