Clearance Summary
COBAS STANDARDS FOR ALBUMIN received FDA 510(k) clearance under submission number K823575, sponsored by Hoffmann-La Roche, Inc.. 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 1983-01-07.
- Submission: K823575
- Applicant / Sponsor: Hoffmann-La Roche, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1035
- Decision date: 1983-01-07
Classification & Regulation
This clearance is catalogued under FDA product code CIX and 21 CFR 862.1035, within the Clinical Chemistry review panel as a Class II device.