Clearance Summary
I-STAT SYSTEM received FDA 510(k) clearance under submission number K992571, sponsored by I-Stat Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2000-02-10.
- Submission: K992571
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7140
- Decision date: 2000-02-10
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.