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FDA 510(k)

B. anthracis Real-time PCR Assay

N.º K: K192871 · 2019-11-07

SolicitanteCenters for Disease Control and Prevention
Fecha de decisión2019-11-07
Código de productoNHT
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

B. anthracis Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192871. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the B. anthracis Real-time PCR Assay?

B. anthracis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K192871.

When did B. anthracis Real-time PCR Assay receive FDA 510(k) clearance?

B. anthracis Real-time PCR Assay received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192871.

Who is the listed applicant for B. anthracis Real-time PCR Assay?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B. anthracis Real-time PCR Assay?

The FDA product code for B. anthracis Real-time PCR Assay is NHT.

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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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