Elecsys CA 15-3 II— 510(k) K181492
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K181492 for Elecsys CA 15-3 II, Substantially Equivalent on 2018-06-22. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code MOI
- Advisory panel
- Immunology
- 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.