ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0— 510(k) K101574
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K101574 for ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0, Substantially Equivalent on 2010-11-23. Applicant: Ark Diagnostics, Inc..
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code OTF
- 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.