The following data is part of a De Novo classification by Ark Diagnostics, Inc with the FDA for Ark Voriconazole Ii Assay Test System.
| DeNovo ID | DEN160033 |
| Device Name: | ARK Voriconazole II Assay Test System |
| Classification | Voriconazole Test System |
| Applicant | ARK DIAGNOSTICS, INC 48089 Fremont Blvd. Fremont, CA 94538 |
| Contact | Kenneth C. Kasper |
| Product Code | PUJ |
| CFR Regulation Number | 862.3970 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Toxicology |
| Classification Advisory | Toxicology |
| Type | Direct |
| Date Received | 2016-07-15 |
| Decision Date | 2017-05-05 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |