ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)— 510(k) K112443
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K112443 for ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN), Substantially Equivalent on 2011-12-19. Applicant: Axis-Shield Diagnostics, Ltd..
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code CDD
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, Scotland, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.