K240315
- 510(k) number
- K240315
- Device name
- INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
- Applicant
- Siemens Healthcare Diagnostics Products GmbH DE
- Product code
- QLU — Anti-Factor Xa Activity Test System, Apixaban
- Decision date
- 2024-10-10
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240315.pdf
Official FDA record: K240315
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.