Reagents, Test, Tetrahydrocannabinol
FDA product code DKE · Class II (moderate risk) · 21 CFR 862.3870 · Clinical Toxicology
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003687 | Verdict II Thc/Coc/Opi/Amp, Verdictii Thc/Coc/Opi,Verdict II Thc/Coc/Amp,Verdict II…DKE · Special | Medtox Diagnostics, Inc. | 12/22/2000SE |
| K994405 | Instant-View Marijuana Urine Cassette TestDKE · Traditional | Alfa Scientific Designs, Inc. | 06/02/2000SE |
| K992068 | Status Stik, Accusign StikDKE · Special | Princeton BioMeditech Corp. | 07/06/1999SE |
| K991751 | Status Cup Accusign CupDKE · Special | Princeton BioMeditech Corp. | 06/18/1999SE |
| K991078 | Accusign DOA8, DOA8 Panel, Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign DOA8…DKE · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K983147 | Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign…DKE · Traditional | Princeton BioMeditech Corp. | 09/28/1998SE |
| K982211 | Profile-Ii Model 600582DKE · Traditional | Medtox Diagnostics, Inc. | 07/29/1998SE |
| K901694 | Spec(Tm) Extraction CartridgeDKE · Traditional | Toxi-Lab, Inc. | 06/01/1990SE |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | Marion Laboratories, Inc. | 07/05/1988SE |
| K841831 | Cannu-Skreen-PreliminaryDKE · Traditional | Biochemical Diagnostic, Inc. | 07/06/1984SE |
| K831456 | Toxi-Lab Cannabinoid THC ScreenDKE · Traditional | Marion Laboratories, Inc. | 06/30/1983SE |
| K792282 | Drugalyzer DTK-1000 Kit Presumptive DrugDKE · Traditional | California Medical Developments, Inc. | 02/29/1980SE |