Clearance Summary
I-STAT SYSTEM received FDA 510(k) clearance under submission number K973292, sponsored by I-Stat Corp.. 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 1997-10-20.
- Submission: K973292
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 1997-10-20
Classification & Regulation
This clearance is catalogued under FDA product code CGL and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.