K173963 is an FDA 510(k) clearance for the DRI Benzodiazepine Assay. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on February 21, 2018, 55 days after receiving the submission on December 28, 2017.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K173963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2017 |
| Decision Date | February 21, 2018 |
| Days to Decision | 55 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 |