FDA 510(k)

Kit de Reagente Total B-hCG Alinity i, Kit de Reagente de Glicose Alinity c, Disolvente de Amostra ICT Alinity c, Série Alinity ci

Número K: K230790 · 2023-05-19

Data da decisão2023-05-19

Código do produtoDHA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230790. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Abbott Laboratories. The 510(k) number is K230790.

When did Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series receive FDA 510(k) clearance?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230790.

Who is the listed applicant for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

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

What is the FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

The FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is DHA.

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Outros registros que listam Abbott Laboratories como candidato(a)

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Ver todos os 28 dispositivos →

Dispositivos Relacionados (Código: DHA)

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Fonte oficial

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