ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)— 510(k) K160757
Substantially EquivalentAxis-Shield Diagnostics Limited
FDA 510(k) clearance K160757 for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM), Substantially Equivalent on 2016-07-26. Applicant: Axis-Shield Diagnostics Limited. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Diagnostics Limited
- 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
- Traditional
- Location
- Dundee, Scotland, GB
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More clearances from Axis-Shield Diagnostics Limited
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