Clearance Summary
i-STAT CHEM8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance under submission number K183680, sponsored by Abbott Point of Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2020-02-28.
- Submission: K183680
- Applicant / Sponsor: Abbott Point of Care, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6400
- Decision date: 2020-02-28
Classification & Regulation
This clearance is catalogued under FDA product code JPI and 21 CFR 864.6400, within the Hematology review panel as a Class II device.