ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C— 510(k) K121842
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K121842 for ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C, Substantially Equivalent on 2012-12-12. Applicant: Axis-Shield Diagnostics, Ltd..
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.