Clearance Summary
I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK received FDA 510(k) clearance under submission number K912387, 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 1991-07-01.
- Submission: K912387
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1665
- Decision date: 1991-07-01
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.