Clearance Summary
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS received FDA 510(k) clearance under submission number K791373, 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 1979-10-26.
- Submission: K791373
- Applicant / Sponsor: Hoffmann-La Roche, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1445
- Decision date: 1979-10-26
Classification & Regulation
This clearance is catalogued under FDA product code CFE and 21 CFR 862.1445, within the Clinical Chemistry review panel as a Class II device.