Elecsys Calcitonin— 510(k) K252431
Substantially EquivalentRoche Diagnostics GmbH
FDA 510(k) clearance K252431 for Elecsys Calcitonin, Substantially Equivalent on 2026-04-24. Applicant: Roche Diagnostics GmbH.
Clearance details
- Applicant
- Roche Diagnostics GmbH
- Product code
- Code JKR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mannheim, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.