Clearance Summary
C1-INHIBITOR MICROTITER ASSAY DEVICE received FDA 510(k) clearance under submission number K003747, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2001-03-19.
- Submission: K003747
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5250
- Decision date: 2001-03-19
Classification & Regulation
This clearance is catalogued under FDA product code DBA and 21 CFR 866.5250, within the Immunology review panel as a Class II device.