Clearance Summary
I-STAT KAOLIN ACT TEST received FDA 510(k) clearance under submission number K023582, sponsored by I-Stat Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2003-09-08.
- Submission: K023582
- Applicant / Sponsor: I-Stat Corporation
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7140
- Decision date: 2003-09-08
Classification & Regulation
This clearance is catalogued under FDA product code JBP and 21 CFR 864.7140, within the Hematology review panel as a Class II device.