FDA 510(k)

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

N.º K: K192046 · 2019-10-28

Fecha de decisión2019-10-28

Código de productoQFO

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2019-10-28 under 510(k) number K192046. The device is classified under product code QFO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is DiaSorin, Inc.. The 510(k) number is K192046.

When did LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set receive FDA 510(k) clearance?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set received FDA 510(k) clearance on 2019-10-28, under 510(k) number K192046.

Who is the listed applicant for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

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

What is the FDA product code for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

The FDA product code for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is QFO.

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Otros registros que enlistan a DiaSorin, Inc. como solicitante

K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HT K223403LIAISON Anti-HAV; LIAISON XS K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus K213936LIAISON MeMed BV, LIAISON MeMed BV Control Set K193650LIAISON Ferritin

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Dispositivos relacionados (Código: QFO)

K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic Systems K191578ADVIA Centaur prueba de Zika, ADVIA Centaur Zika Ab (100 pruebas), ADVIA Centaur Zika IgM (50 pruebas), ADVIA Centaur Zika Ab Control de Calidad, ADVIA Centaur Zika IgM Control de CalidadSiemens Healthcare Diagnostics, Inc.

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.