Clearance Summary
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE received FDA 510(k) clearance under submission number K897060, 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 1990-01-02.
- Submission: K897060
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8185
- Decision date: 1990-01-02
Classification & Regulation
This clearance is catalogued under FDA product code KSA and 21 CFR 864.8185, within the Hematology review panel as a Class II device.