Clearance Summary
I-STAT CARDIAC TROPONIN (CTNI) TEST received FDA 510(k) clearance under submission number K031739, 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 2003-09-02.
- Submission: K031739
- Applicant / Sponsor: I-Stat Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2003-09-02
Classification & Regulation
This clearance is catalogued under FDA product code MMI and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.