FDA 510(k)

Xprecia Stride Coagulation System, Xprecia System PT Controls

N.º K: K151964 · 2016-09-30

SolicitanteSiemens Healthcare Diagnostics

Fecha de decisión2016-09-30

Código de productoGJS

Comité asesorHE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Xprecia Stride Coagulation System, Xprecia System PT Controls is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K151964. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Xprecia Stride Coagulation System, Xprecia System PT Controls?

Xprecia Stride Coagulation System, Xprecia System PT Controls is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K151964.

When did Xprecia Stride Coagulation System, Xprecia System PT Controls receive FDA 510(k) clearance?

Xprecia Stride Coagulation System, Xprecia System PT Controls received FDA 510(k) clearance on 2016-09-30, under 510(k) number K151964.

Who is the listed applicant for Xprecia Stride Coagulation System, Xprecia System PT Controls?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls?

The FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls is GJS.

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Otros registros que enlistan a Siemens Healthcare Diagnostics como solicitante

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Dispositivos relacionados (Código: GJS)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.