Clearance Summary
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K942451, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1994-11-10.
- Submission: K942451
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1994-11-10
Classification & Regulation
This clearance is catalogued under FDA product code LDM and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.