Clearance Summary
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE received FDA 510(k) clearance under submission number K912357, 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 1991-07-09.
- Submission: K912357
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8150
- Decision date: 1991-07-09
Classification & Regulation
This clearance is catalogued under FDA product code KRX and 21 CFR 864.8150, within the Hematology review panel as a Class II device.