K253491

Substantially Equivalent

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
Product code: CEM
Advisory panel: Clinical Chemistry
Date received: 2025-10-24
Decision date: 2026-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.