Clearance Summary
FIAX C4 ASSAY received FDA 510(k) clearance under submission number K772114, sponsored by Idt, A Division of Whittaker M.A. Bioproducts. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1977-11-30.
- Submission: K772114
- Applicant / Sponsor: Idt, A Division of Whittaker M.A. Bioproducts
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 1977-11-30
Classification & Regulation
This clearance is catalogued under FDA product code DAK and 21 CFR 866.5240, within the Immunology review panel as a Class II device.