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

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..

Clearance details

Applicant: Affinity Biologicals, Inc.
Product code: Code GGN
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.