Clearance Summary
I-STAT SYSTEM received FDA 510(k) clearance under submission number K011478, 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 2001-07-02.
- Submission: K011478
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1450
- Decision date: 2001-07-02
Classification & Regulation
This clearance is catalogued under FDA product code KHP and 21 CFR 862.1450, within the Clinical Chemistry review panel as a Class I device.