Clearance Summary
INNOVANCE D-DIMER, MODEL OPBP09 received FDA 510(k) clearance under submission number K091916, sponsored by Siemens Healthcare Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-10-29.
- Submission: K091916
- Applicant / Sponsor: Siemens Healthcare Diagnostics
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 2009-10-29
Classification & Regulation
This clearance is catalogued under FDA product code DAP and 21 CFR 864.7320, within the Hematology review panel as a Class II device.