K200363 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 March 11, 2020, 26 days after receiving the submission on February 14, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K200363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2020 |
| Decision Date | March 11, 2020 |
| Days to Decision | 26 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 |