ARK Voriconazole II Assay Test System
FDA 510(k) clearance DEN160033 · decided 2017-05-05
Clearance details
- K-number
- DEN160033
- Device name
- ARK Voriconazole II Assay Test System
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2016-07-15
- Decision date
- 2017-05-05
- Days to decision
- 294 days
- Clearance type
- Direct
- Product code
- PUJ
- Device class
- 2
- Regulation number
- 862.3970
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ark Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.