Clearance Summary
AMERLITE FERRITIN II ASSAY received FDA 510(k) clearance under submission number K952286, sponsored by Johnson & Johnson Clinical Diagnostics, 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 1995-06-20.
- Submission: K952286
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1995-06-20
Classification & Regulation
This clearance is catalogued under FDA product code DBF and 21 CFR 866.5340, within the Immunology review panel as a Class II device.