K190968 is an FDA 510(k) clearance for the CEDIA 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 December 9, 2019, 241 days after receiving the submission on April 12, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K190968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2019 |
| Decision Date | December 09, 2019 |
| Days to Decision | 241 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 |