Clearance Summary
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance under submission number K884683, sponsored by Serono-Baker 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 1988-12-27.
- Submission: K884683
- Applicant / Sponsor: Serono-Baker Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1988-12-27
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.