ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5— 510(k) K112624
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K112624 for ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5, Substantially Equivalent on 2012-09-10. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code OIU
- 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.