Submission Details
| 510(k) Number | K994405 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
Jun 2000
Decision
157d
Days
Class 2
Risk
About This 510(k) Submission
K994405 is an FDA 510(k) clearance for the INSTANT-VIEW MARIJUANA URINE CASSETTE TEST, 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 review panel. Regulated under 21 CFR 862.3870.
Device Classification
| Product Code | DKE — Reagents, Test, Tetrahydrocannabinol |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |
Manufacturer
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