TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00— 510(k) K083799
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K083799 for TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00, Substantially Equivalent on 2009-04-16. Applicant: Ark Diagnostics, Inc..
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code NWM
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.