FDA 510(k)

ISE indirecto K para Gen.2; ISE indirecto Na para Gen.2; ISE indirecto Cl para Gen.2; soluciones integradas cobas pro

N.º K: K253491 · 2026-02-12

Fecha de decisión2026-02-12

Código de productoCEM

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K253491. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions?

ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Roche Diagnostics. The 510(k) number is K253491.

When did ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions receive FDA 510(k) clearance?

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 on 2026-02-12, under 510(k) number K253491.

Who is the listed applicant for ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions?

The FDA product code for ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions is CEM.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.