K994405 is an FDA 510(k) clearance for the INSTANT-VIEW MARIJUANA URINE CASSETTE TEST. This device is classified as a Reagents, Test, Tetrahydrocannabinol (Class II - Special Controls, product code DKE).
Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on June 2, 2000, 157 days after receiving the submission on December 28, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K994405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1999 |
| Decision Date | June 02, 2000 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKE — Reagents, Test, Tetrahydrocannabinol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |