FDA 510(k)

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Ensayo

N.º K: K172133 · 2017-10-27

SolicitanteAxis-Shield Diagnostics, Ltd.

Fecha de decisión2017-10-27

Código de productoCDD

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay 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 2017-10-27 under 510(k) number K172133. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay?

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K172133.

When did ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay receive FDA 510(k) clearance?

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172133.

Who is the listed applicant for ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay?

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 ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay?

The FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay is CDD.

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Otros registros que enlistan a Axis-Shield Diagnostics, Ltd. como solicitante

K253539Alere NT-proBNP para Alinity i K241176Alere NT-proBNP para Alinity i Reagent Kit K233541ARCHITECT Activo-B12 (Holotranscobalamin)

Dispositivos relacionados (Código: CDD)

K233541ARCHITECT Activo-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.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.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Ensayo, ADVIA Centaur Active-B12(AB12) Control de Calidad y Materiales de Curva Maestra (MCM) de ADVIA Centaur Active-B12 (AB12)Axis-Shield Diagnostics Limited

Fuente oficial

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