Clearance Summary
HYCEL DILUTOR, VARIOUS MODELS/MULTI received FDA 510(k) clearance under submission number K842747, 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 1984-10-01.
- Submission: K842747
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.5240
- Decision date: 1984-10-01
Classification & Regulation
This clearance is catalogued under FDA product code GKH and 21 CFR 864.5240, within the Hematology review panel as a Class I device.