ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
FDA 510(k) clearance K160757 · decided 2016-07-26
Clearance details
- K-number
- K160757
- Device name
- ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
- Applicant
- Axis-Shield Diagnostics Limited
- Decision
- Substantially Equivalent
- Date received
- 2016-03-18
- Decision date
- 2016-07-26
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- CDD
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Dundee, Scotland, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.