Clearance Summary
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 received FDA 510(k) clearance under submission number K141375, sponsored by Phadia US, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-02-13.
- Submission: K141375
- Applicant / Sponsor: Phadia US, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5090
- Decision date: 2015-02-13
Classification & Regulation
This clearance is catalogued under FDA product code DBM and 21 CFR 866.5090, within the Immunology review panel as a Class II device.