Clearance Summary
I-STAT PROTHROMBIN TIME TEST received FDA 510(k) clearance under submission number K020355, sponsored by I-Stat Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2002-05-14.
- Submission: K020355
- Applicant / Sponsor: I-Stat Corporation
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 2002-05-14
Classification & Regulation
This clearance is catalogued under FDA product code GJS and 21 CFR 864.7750, within the Hematology review panel as a Class II device.