Clearance Summary
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 received FDA 510(k) clearance under submission number K001387, 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 2000-10-05.
- Submission: K001387
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2000-10-05
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.