ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003— 510(k) K091884
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K091884 for ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003, Substantially Equivalent on 2009-12-09. 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.