Clearance Summary
CDS HEMATOLOGY CALIBRATOR (CDS CAL) received FDA 510(k) clearance under submission number K041130, sponsored by Clinical Diagnostic Solutions, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-06-10.
- Submission: K041130
- Applicant / Sponsor: Clinical Diagnostic Solutions, Inc.
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8165
- Decision date: 2004-06-10
Classification & Regulation
This clearance is catalogued under FDA product code KRZ and 21 CFR 864.8165, within the Hematology review panel as a Class II device.