Clearance Summary
INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP received FDA 510(k) clearance under submission number K110212, sponsored by Alere San Diego, Inc (Formally Biosite Incorporate. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2012-05-01.
- Submission: K110212
- Applicant / Sponsor: Alere San Diego, Inc (Formally Biosite Incorporate
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 2012-05-01
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.