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FDA 510(k)

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

N.º K: K202755 · 2022-11-05

SolicitanteDiasorin Molecular, LLC
Fecha de decisión2022-11-05
Código de productoQDZ
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2022-11-05 under 510(k) number K202755. The device is classified under product code QDZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2022-11-05. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K202755.

When did Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack receive FDA 510(k) clearance?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack received FDA 510(k) clearance on 2022-11-05, under 510(k) number K202755.

Who is the listed applicant for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

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

What is the FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

The FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is QDZ.

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Otros registros que enlistan a Diasorin Molecular, LLC 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.

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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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