Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet— 510(k) K151786
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K151786 for Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet, Substantially Equivalent on 2015-09-24. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CDD
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.