Instant-View Marijuana Urine Cassette Test
FDA 510(k) K994405 · Alfa Scientific Designs, Inc.
510(k) numberK994405
Submission
- Device name
- Instant-View Marijuana Urine Cassette Test
- Applicant
- Alfa Scientific Designs, Inc.
San Diego, CA, US - Received
- December 28, 1999
- Decision date
- June 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
More from Marion Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | 07/25/2006SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | 11/19/2004SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
Questions and answers
When was Instant-View Marijuana Urine Cassette Test cleared by the FDA?
Instant-View Marijuana Urine Cassette Test (K994405) received a 510(k) decision of Substantially Equivalent on June 2, 2000, 157 days after the submission was received.
What is the product code of K994405?
The FDA product code is DKE – Reagents, Test, Tetrahydrocannabinol, a Class II (moderate risk) device regulated under 21 CFR 862.3870.