ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control— 510(k) K153596
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K153596 for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control, Substantially Equivalent on 2016-08-09. Applicant: Ark Diagnostics, Inc..
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code POX
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.