INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)— 510(k) K240315
Substantially EquivalentSiemens Healthcare Diagnostics Products GmbH
FDA 510(k) clearance K240315 for INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05), Substantially Equivalent on 2024-10-10. Applicant: Siemens Healthcare Diagnostics Products GmbH.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
- Product code
- Code QLU
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marburg, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.