Clearance Summary
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions received FDA 510(k) clearance under submission number K253491, 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 2026-02-12.
- Submission: K253491
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1600
- Decision date: 2026-02-12
Classification & Regulation
This clearance is catalogued under FDA product code CEM and 21 CFR 862.1600, within the Clinical Chemistry review panel as a Class II device.