Clearance Summary
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER received FDA 510(k) clearance under submission number K012478, 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 2001-08-20.
- Submission: K012478
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1120
- Decision date: 2001-08-20
Classification & Regulation
This clearance is catalogued under FDA product code CHL and 21 CFR 862.1120, within the Clinical Chemistry review panel as a Class II device.