510(k) DEN160033
DEN160033 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK Voriconazole II Assay Test System". The FDA issued a decision of De Novo Granted on May 5, 2017. The device falls under product code PUJ (Voriconazole Test System), a Class II device regulated under 21 CFR 862.3970. Ark Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 5, 2017
- Date Received
- July 15, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Voriconazole Test System
- Device Class
- Class II
- Regulation Number
- 862.3970
- Review Panel
- TX
- Submission Type
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.