K253491
- 510(k) number
- K253491
- Device name
- ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
- Applicant
- Roche Diagnostics IN · US
- Product code
- CEM — Electrode, Ion Specific, Potassium
- Decision date
- 2026-02-12
- Date received
- 2025-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253491.pdf
Official FDA record: K253491
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.