Clearance Summary
RIA-QUANT FPA TEST KIT received FDA 510(k) clearance under submission number K821151, sponsored by Mallinckrodt Critical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1982-07-22.
- Submission: K821151
- Applicant / Sponsor: Mallinckrodt Critical Care
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5350
- Decision date: 1982-07-22
Classification & Regulation
This clearance is catalogued under FDA product code DAN and 21 CFR 866.5350, within the Immunology review panel as a Class II device.