Clearance Summary
RENAK received FDA 510(k) clearance under submission number K831694, 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 1983-07-19.
- Submission: K831694
- Applicant / Sponsor: Hoffmann-La Roche, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1085
- Decision date: 1983-07-19
Classification & Regulation
This clearance is catalogued under FDA product code CIB and 21 CFR 862.1085, within the Clinical Chemistry review panel as a Class II device.