510(k) DEN160033
- Device
- ARK Voriconazole II Assay Test System
- Applicant
- Ark Diagnostics, Inc.
- 510(k) number
- DEN160033
- Product code
- PUJ
- Decision
- Unknown (DENG)
- Decision date
- 2017-05-05
- Date received
- 2016-07-15
- Regulation
- 862.3970
- Classification name
- Voriconazole Test System
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kenneth C. Kasper
- Address
- 48089 Fremont Blvd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3005755244
Source Documents#
510(k) summary PDF not indicated by FDA