K182719 is an FDA 510(k) clearance for the Quidel Triage TOX Drug Screen, 94600. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Quidel Cardiovascular, Inc. (San Diego, US). The FDA issued a Cleared decision on June 19, 2019, 264 days after receiving the submission on September 28, 2018.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K182719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | June 19, 2019 |
| Days to Decision | 264 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 |