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FDA 510(k)

VisuCon-F Low Fibrinogen Control Plasma

K-Number: K150144 · 2016-03-06

ApplicantAffinity Biologicals, Inc.
Decision Date2016-03-06
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Affinity Biologicals, Inc.. The 510(k) number is K150144.

When was VisuCon-F Low Fibrinogen Control Plasma approved by the FDA?

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

What company makes VisuCon-F Low Fibrinogen Control Plasma?

VisuCon-F Low Fibrinogen Control Plasma is manufactured by Affinity Biologicals, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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