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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 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.

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. 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.

Related Devices (Code: GGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC

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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