Clearance Summary
ACCESS FERRITIN ASSAY received FDA 510(k) clearance under submission number K926221, sponsored by Bio-Rad Laboratories, 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 1993-01-13.
- Submission: K926221
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1993-01-13
Classification & Regulation
This clearance is catalogued under FDA product code JMG and 21 CFR 866.5340, within the Immunology review panel as a Class II device.