Clearance Summary
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. received FDA 510(k) clearance under submission number K002107, 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 2000-08-04.
- Submission: K002107
- Applicant / Sponsor: Scimedx Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2000-08-04
Classification & Regulation
This clearance is catalogued under FDA product code MVM and 21 CFR 866.5660, within the Immunology review panel as a Class II device.