Toxi-Lab Cannabinoid THC Screen
FDA 510(k) K831456 · Marion Laboratories, Inc.
510(k) numberK831456
Submission
- Device name
- Toxi-Lab Cannabinoid THC Screen
- Applicant
- Marion Laboratories, Inc.
Walker, MI, US - Received
- May 6, 1983
- Decision date
- June 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKE – Reagents, Test, Tetrahydrocannabinol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKE
| 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 |
More from Biochemical Diagnostic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Toxi-Lab Cannabinoid THC Screen cleared by the FDA?
Toxi-Lab Cannabinoid THC Screen (K831456) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 55 days after the submission was received.
What is the product code of K831456?
The FDA product code is DKE – Reagents, Test, Tetrahydrocannabinol, a Class II (moderate risk) device regulated under 21 CFR 862.3870.