K022564 is an FDA 510(k) clearance for the INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on August 30, 2002, 28 days after receiving the submission on August 2, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K022564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2002 |
| Decision Date | August 30, 2002 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |