Clearance Summary
SCIMEDX PHASE II MPO IGG ANTIBODY EIA received FDA 510(k) clearance under submission number K010289, sponsored by Scimedx 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 2001-03-07.
- Submission: K010289
- Applicant / Sponsor: Scimedx Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2001-03-07
Classification & Regulation
This clearance is catalogued under FDA product code MOB and 21 CFR 866.5660, within the Immunology review panel as a Class II device.