Clearance Summary
I-STAT IONIZED CALCIUM TEST received FDA 510(k) clearance under submission number K934642, 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 1993-12-17.
- Submission: K934642
- Applicant / Sponsor: I-Stat Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1145
- Decision date: 1993-12-17
Classification & Regulation
This clearance is catalogued under FDA product code JFP and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.