ARK Voriconazole II Assay Test System— 510(k) DEN160033
UnknownArk Diagnostics, Inc.
FDA 510(k) clearance DEN160033 for ARK Voriconazole II Assay Test System, Unknown on 2017-05-05. Applicant: Ark Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code PUJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3970
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Fremont, CA, US
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