ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay— 510(k) K172133
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K172133 for ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay, Substantially Equivalent on 2017-10-27. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dundee, GB
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