510(k) K160757
K160757 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics Limited for the device "ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)". The FDA issued a decision of Substantially Equivalent on July 26, 2016. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Axis-Shield Diagnostics Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2016
- Date Received
- March 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Vitamin B12
- Device Class
- Class II
- Regulation Number
- 862.1810
- Review Panel
- CH
- Submission Type