Clearance Summary
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN received FDA 510(k) clearance under submission number K010455, sponsored by Diagnostica-Stago. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2001-06-07.
- Submission: K010455
- Applicant / Sponsor: Diagnostica-Stago
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7525
- Decision date: 2001-06-07
Classification & Regulation
This clearance is catalogued under FDA product code KFF and 21 CFR 864.7525, within the Hematology review panel as a Class II device.