PUJ — Voriconazole Test System Class II
FDA product code PUJ covers "Voriconazole Test System", a Class II medical device regulated under 21 CFR 862.3970. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PUJ
- Device Class
- Class II
- Regulation Number
- 862.3970
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN160033 | ark diagnostics | ARK Voriconazole II Assay Test System | May 5, 2017 |