Clearance Summary
i-STAT CHEM8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance under submission number K191360, sponsored by Abbott Point of Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-02-14.
- Submission: K191360
- Applicant / Sponsor: Abbott Point of Care, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1145
- Decision date: 2020-02-14
Classification & Regulation
This clearance is catalogued under FDA product code JFP and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.