ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions— 510(k) K253491

Name: FDA 510(k) clearance K253491
Creator: U.S. Food and Drug Administration
Published: 2026-02-12

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K253491 for ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions, Substantially Equivalent on 2026-02-12. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2025-10-24
Decision date: 2026-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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