VisuCon-F Low Fibrinogen Control Plasma— 510(k) K150144

Name: FDA 510(k) clearance K150144
Creator: U.S. Food and Drug Administration
Published: 2016-03-06

Substantially Equivalent

Affinity Biologicals, Inc.

FDA 510(k) clearance K150144 for VisuCon-F Low Fibrinogen Control Plasma, Substantially Equivalent on 2016-03-06. Applicant: Affinity Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Affinity Biologicals, Inc.
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2015-01-22
Decision date: 2016-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancaster, CA

Download summary PDF View on FDA.gov ↗

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