Clearance Summary
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET received FDA 510(k) clearance under submission number K031873, sponsored by I-Stat Corporation. 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 2003-10-07.
- Submission: K031873
- Applicant / Sponsor: I-Stat Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2003-10-07
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.