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. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- 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
- Indianapolis, IN, US
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More clearances from Roche Diagnostics
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