Elecsys Cortisol II, Cortisol II CalSet— 510(k) K152227
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K152227 for Elecsys Cortisol II, Cortisol II CalSet, Substantially Equivalent on 2016-04-27. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code JFT
- 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.