Clearance Summary
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) received FDA 510(k) clearance under submission number K240315, sponsored by Siemens Healthcare Diagnostics Products GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-10-10.
- Submission: K240315
- Applicant / Sponsor: Siemens Healthcare Diagnostics Products GmbH
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7295
- Decision date: 2024-10-10
Classification & Regulation
This clearance is catalogued under FDA product code QLU and 21 CFR 864.7295, within the Hematology review panel as a Class II device.