Clearance Summary
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay received FDA 510(k) clearance under submission number K182353, 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 2018-11-27.
- Submission: K182353
- Applicant / Sponsor: Phadia AB
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2018-11-27
Classification & Regulation
This clearance is catalogued under FDA product code LJM and 21 CFR 866.5100, within the Immunology review panel as a Class II device.