Clearance Summary
HYCEL ROTOR-MIXER AND/OR MULTI received FDA 510(k) clearance under submission number K842746, 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 1984-08-17.
- Submission: K842746
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.9195
- Decision date: 1984-08-17
Classification & Regulation
This clearance is catalogued under FDA product code KSQ and 21 CFR 864.9195, within the Hematology review panel as a Class I device.