510(k) K151786
K151786 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet". The FDA issued a decision of Substantially Equivalent on September 24, 2015. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2015
- Date Received
- July 1, 2015
- 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