K201494 is an FDA 510(k) clearance for the ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Advin Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 17, 2020, 104 days after receiving the submission on June 5, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K201494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2020 |
| Decision Date | September 17, 2020 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG - Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |