K152122 is an FDA 510(k) clearance for the Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use). This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Alfa Scientific Designs, Inc. (Powat, US). The FDA issued a Cleared decision on June 24, 2016, 330 days after receiving the submission on July 30, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K152122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2015 |
| Decision Date | June 24, 2016 |
| Days to Decision | 330 days |
| Submission Type | Traditional |
| 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 |