Clearance Summary
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay received FDA 510(k) clearance under submission number K181871, sponsored by Phadia AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-03-01.
- Submission: K181871
- Applicant / Sponsor: Phadia AB
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2019-03-01
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.