ARCHITECT Active-B12 (Holotranscobalamin)— 510(k) K233541
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K233541 for ARCHITECT Active-B12 (Holotranscobalamin), Substantially Equivalent on 2024-07-31. 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
- Traditional
- Location
- Dundee, GB
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