FDA 510(k)

VisuCon-F Low Fibrinogen Control Plasma

Número K: K150144 · 2016-03-06

Data da decisão2016-03-06

Código do produtoGGN

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

VisuCon-F Low Fibrinogen Control Plasma is the device name listed in this FDA 510(k) record. The listed applicant is Affinity Biologicals, Inc.. It received FDA 510(k) clearance on 2016-03-06 under 510(k) number K150144. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VisuCon-F Low Fibrinogen Control Plasma?

VisuCon-F Low Fibrinogen Control Plasma is a medical device that received FDA 510(k) clearance on 2016-03-06. The listed applicant is Affinity Biologicals, Inc.. The 510(k) number is K150144.

When did VisuCon-F Low Fibrinogen Control Plasma receive FDA 510(k) clearance?

VisuCon-F Low Fibrinogen Control Plasma received FDA 510(k) clearance on 2016-03-06, under 510(k) number K150144.

Who is the listed applicant for VisuCon-F Low Fibrinogen Control Plasma?

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

What is the FDA product code for VisuCon-F Low Fibrinogen Control Plasma?

The FDA product code for VisuCon-F Low Fibrinogen Control Plasma is GGN.

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