Clearance Summary
COBAS-BLO REAGENTS (LACTATE DEHYDRO received FDA 510(k) clearance under submission number K792658, 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 1980-01-17.
- Submission: K792658
- Applicant / Sponsor: Hoffmann-La Roche, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1440
- Decision date: 1980-01-17
Classification & Regulation
This clearance is catalogued under FDA product code CFJ and 21 CFR 862.1440, within the Clinical Chemistry review panel as a Class II device.