K221765 is an FDA 510(k) clearance for the ONLINE DAT Benzodiazepines II. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 23, 2022, 189 days after receiving the submission on June 17, 2022.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K221765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2022 |
| Decision Date | December 23, 2022 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |