Clearance Summary
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 received FDA 510(k) clearance under submission number K123726, sponsored by Roche Diagnostics. 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 2013-05-21.
- Submission: K123726
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1665
- Decision date: 2013-05-21
Classification & Regulation
This clearance is catalogued under FDA product code JGS and 21 CFR 862.1665, within the Clinical Chemistry review panel as a Class II device.