Clearance Summary
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM received FDA 510(k) clearance under submission number K900775, 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 1990-03-09.
- Submission: K900775
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 1990-03-09
Classification & Regulation
This clearance is catalogued under FDA product code JQW and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.