Clearance Summary
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER received FDA 510(k) clearance under submission number K001154, sponsored by I-Stat Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-04-18.
- Submission: K001154
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1665
- Decision date: 2000-04-18
Classification & Regulation
This clearance is catalogued under FDA product code JGS and 21 CFR 862.1665, within the Clinical Chemistry review panel as a Class II device.