Clearance Summary
FACTOR II (PROTHROMBIN) G20210A KIT received FDA 510(k) clearance under submission number K033612, sponsored by Roche Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2003-12-18.
- Submission: K033612
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7280
- Decision date: 2003-12-18
Classification & Regulation
This clearance is catalogued under FDA product code NPR and 21 CFR 864.7280, within the Hematology review panel as a Class II device.