FDA 510(k)

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

N.º K: K253490 · 2026-02-12

Fecha de decisión2026-02-12

Código de productoCFR

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Glucose HK Gen.3; ONLINE DAT Methadone II; 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 K253490. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

Glucose HK Gen.3; ONLINE DAT Methadone II; 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 K253490.

When did Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions receive FDA 510(k) clearance?

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253490.

Who is the listed applicant for Glucose HK Gen.3; ONLINE DAT Methadone II; 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 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

The FDA product code for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is CFR.

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Dispositivos relacionados (Código: CFR)

K252357Glucose2Abbott Ireland K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche Diagnostics K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup K151487Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase MethodDiatron U.S., Inc.

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.