Elecsys CA-125 II assay— 510(k) K143534
Substantially EquivalentRoche Professional Diagnostics
FDA 510(k) clearance K143534 for Elecsys CA-125 II assay, Substantially Equivalent on 2015-08-06. Applicant: Roche Professional Diagnostics.
Clearance details
- Applicant
- Roche Professional Diagnostics
- Product code
- Code LTK
- 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.