FDA 510(k)

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

N.º K: K153361 · 2016-04-15

Fecha de decisión2016-04-15

Código de productoMRG

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K153361. 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 Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K153361.

When did Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators receive FDA 510(k) clearance?

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators received FDA 510(k) clearance on 2016-04-15, under 510(k) number K153361.

Who is the listed applicant for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

The FDA 510(k) record lists Fujirebio Diagnostics,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

The FDA product code for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is MRG.

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Otros registros que enlistan a Fujirebio Diagnostics,Inc. como solicitante

K250925ADVIA Centaur Fragmento de Citoqueratina 21-1 K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP K200997Lumipulse G CA19-9-N K190702Lumipulse G whole PTH

Ver todos los 17 dispositivos →

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

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.