Clearance Summary
LPIA-FERRITIN ASSAY received FDA 510(k) clearance under submission number K924186, sponsored by Seradyn, 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 1992-12-23.
- Submission: K924186
- Applicant / Sponsor: Seradyn, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5425
- Decision date: 1992-12-23
Classification & Regulation
This clearance is catalogued under FDA product code DEF and 21 CFR 866.5425, within the Immunology review panel as a Class I device.