FDA 510(k)

BioPlex 2200 25-OH Vitamin D Kit

N.º K: K180577 · 2018-06-22

Fecha de decisión2018-06-22

Código de productoMRG

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

BioPlex 2200 25-OH Vitamin D Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180577. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BioPlex 2200 25-OH Vitamin D Kit?

BioPlex 2200 25-OH Vitamin D Kit is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K180577.

When did BioPlex 2200 25-OH Vitamin D Kit receive FDA 510(k) clearance?

BioPlex 2200 25-OH Vitamin D Kit received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180577.

Who is the listed applicant for BioPlex 2200 25-OH Vitamin D Kit?

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

What is the FDA product code for BioPlex 2200 25-OH Vitamin D Kit?

The FDA product code for BioPlex 2200 25-OH Vitamin D Kit is MRG.

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Otros registros que enlistan a Bio-Rad Laboratories como solicitante

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Dispositivos relacionados (Código: MRG)

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS VITAMINA D, ANALIZADOR ALFIS-3Immunostics Inc.,K223503Access 25(OH) Vitamina D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche Diagnostics K200509ADVIA Centaur Vitamina D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.

Fuente oficial

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