FDA 510(k)

vWF Ag

N.º K: K220728 · 2023-06-02

SolicitanteSiemens Healthcare Diagnostics Products GmbH

Fecha de decisión2023-06-02

Código de productoGGP

Comité asesorHE

DecisiónSubstantially Equivalent

Resumen del dispositivo

vWF Ag is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K220728. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the vWF Ag?

vWF Ag is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K220728.

When did vWF Ag receive FDA 510(k) clearance?

vWF Ag received FDA 510(k) clearance on 2023-06-02, under 510(k) number K220728.

Who is the listed applicant for vWF Ag?

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

What is the FDA product code for vWF Ag?

The FDA product code for vWF Ag is GGP.

Otros registros que enlistan a Siemens Healthcare Diagnostics Products GmbH 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.

K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)K212559CardioPhase® hsCRP K212379N Latex FLC kappa, N Latex FLC lambda K201496N Latex FLC kappa, N Latex FLC lambda K193047N Latex FLC kappa, N Latex FLC lambda

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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.