Clearance Summary
REFACTO LABORATORY STANDARD received FDA 510(k) clearance under submission number K002350, sponsored by The Genetics Institute. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2000-10-05.
- Submission: K002350
- Applicant / Sponsor: The Genetics Institute
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 2000-10-05
Classification & Regulation
This clearance is catalogued under FDA product code GGP and 21 CFR 864.7290, within the Hematology review panel as a Class II device.