Clearance Summary
HemoCue Hb 301 System received FDA 510(k) clearance under submission number K201217, sponsored by Hemocue AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2020-08-04.
- Submission: K201217
- Applicant / Sponsor: Hemocue AB
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5620
- Decision date: 2020-08-04
Classification & Regulation
This clearance is catalogued under FDA product code GKR and 21 CFR 864.5620, within the Hematology review panel as a Class II device.