DEN160033 is an FDA 510(k) submission for the ARK Voriconazole II Assay Test System. This device is classified as a Voriconazole Test System (Class II - Special Controls, product code PUJ).
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Not Cleared (DENG) decision on May 5, 2017.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3970. A Voriconazole Test System Is A Device Intended To Measure Voriconazole In Human Serum. Measurements Obtained By This Device Are Used In Monitoring Levels Of Voriconazole To Ensure Appropriate Therapy..
| 510(k) Number | DEN160033 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 15, 2016 |
| Decision Date | May 05, 2017 |
| Days to Decision | 294 days |
| Submission Type | Direct |
| Review Panel | Toxicology (TX) |
| Summary | - |
| Product Code | PUJ - Voriconazole Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3970 |
| Definition | A Voriconazole Test System Is A Device Intended To Measure Voriconazole In Human Serum. Measurements Obtained By This Device Are Used In Monitoring Levels Of Voriconazole To Ensure Appropriate Therapy. |