FDA 510(k)

Kit de 12 Alérgenos para la Prueba de IgE Específica de Alergeno

N.º K: K193613 · 2021-10-18

SolicitanteHitachi Chemical Diagnostics, Inc.

Fecha de decisión2021-10-18

Código de productoDHB

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Allergen-Specific IgE Assay 12 Allergen Bundle is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K193613. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Allergen-Specific IgE Assay 12 Allergen Bundle?

Allergen-Specific IgE Assay 12 Allergen Bundle is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K193613.

When did Allergen-Specific IgE Assay 12 Allergen Bundle receive FDA 510(k) clearance?

Allergen-Specific IgE Assay 12 Allergen Bundle received FDA 510(k) clearance on 2021-10-18, under 510(k) number K193613.

Who is the listed applicant for Allergen-Specific IgE Assay 12 Allergen Bundle?

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

What is the FDA product code for Allergen-Specific IgE Assay 12 Allergen Bundle?

The FDA product code for Allergen-Specific IgE Assay 12 Allergen Bundle is DHB.

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Otros registros que enlistan a Hitachi Chemical Diagnostics, Inc. como solicitante

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Dispositivos relacionados (Código: DHB)

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Fuente oficial

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