Clearance Summary
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 received FDA 510(k) clearance under submission number K071319, sponsored by Bio-Rad, Diagnostics Grp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-06-26.
- Submission: K071319
- Applicant / Sponsor: Bio-Rad, Diagnostics Grp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2007-06-26
Classification & Regulation
This clearance is catalogued under FDA product code GGN and 21 CFR 864.5425, within the Hematology review panel as a Class II device.