Clearance Summary
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE received FDA 510(k) clearance under submission number K913879, 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 1991-11-27.
- Submission: K913879
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 1991-11-27
Classification & Regulation
This clearance is catalogued under FDA product code JPK and 21 CFR 864.8625, within the Hematology review panel as a Class II device.