FDA 510(k)

ARCHITECT Ativo-B12 (Holotranscobalamin)

Número K: K233541 · 2024-07-31

Data da decisão2024-07-31

Código do produtoCDD

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARCHITECT Active-B12 (Holotranscobalamin) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233541. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K233541.

When did ARCHITECT Active-B12 (Holotranscobalamin) receive FDA 510(k) clearance?

ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233541.

Who is the listed applicant for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA product code for ARCHITECT Active-B12 (Holotranscobalamin) is CDD.

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Outros registros que listam Axis-Shield Diagnostics, Ltd. como candidato(a)

K253539Alere NT-proBNP para Alinity i K241176Alere NT-proBNP para Alinity i Kit de Reagentes K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Ensaio

Dispositivos Relacionados (Código: CDD)

K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH K192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) EnsaioAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Ensaio, ADVIA Centaur Active-B12(AB12) Controle de Qualidade e Materiais da Curva Mestre do ADVIA Centaur Active-B12 (AB12) (MCM)Axis-Shield Diagnostics Limited

Fonte oficial

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