Clearance Summary
STATUSFLOW received FDA 510(k) clearance under submission number K982231, sponsored by R&D Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1998-07-20.
- Submission: K982231
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1998-07-20
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.