Clearance Summary
i-STAT TBI Plasma cartridge with the i-STAT Alinity System received FDA 510(k) clearance under submission number K201778, sponsored by Abbott Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2021-01-08.
- Submission: K201778
- Applicant / Sponsor: Abbott Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5830
- Decision date: 2021-01-08
Classification & Regulation
This clearance is catalogued under FDA product code QAT and 21 CFR 866.5830, within the Immunology review panel as a Class II device.