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FDA 510(k)

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

N.º K: K160829 · 2016-06-13

SolicitanteMeridian Bioscience, Inc.
Fecha de decisión2016-06-13
Código de productoOZX
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K160829. The device is classified under product code OZX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K160829.

When did illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 receive FDA 510(k) clearance?

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 received FDA 510(k) clearance on 2016-06-13, under 510(k) number K160829.

Who is the listed applicant for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?

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

What is the FDA product code for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?

The FDA product code for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is OZX.

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Otros registros que enlistan a Meridian Bioscience, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K243922RevogeneK230901Premier HpSA Flex (619096)K222829Curian® Shiga ToxinK222779RevogeneK220480RevogeneK210976Curian Campy

Ver todos los 11 dispositivos →

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.

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