ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.— 510(k) K153551
Substantially EquivalentAxis-Shield Diagnostics Limited
FDA 510(k) clearance K153551 for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials., Substantially Equivalent on 2016-08-04. Applicant: Axis-Shield Diagnostics Limited.
Clearance details
- Applicant
- Axis-Shield Diagnostics Limited
- Product code
- Code NHX
- Advisory panel
- Immunology
- 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.