Clearance Summary
HGB3 (1:251) received FDA 510(k) clearance under submission number K802266, sponsored by R&D Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1980-10-23.
- Submission: K802266
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5620
- Decision date: 1980-10-23
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.