Cleared Traditional

VisuCon-F Low Fibrinogen Control Plasma

K150144 · Affinity Biologicals, Inc. · Hematology
Mar 2016
Decision
409d
Days
Class 2
Risk

About This 510(k) Submission

K150144 is an FDA 510(k) clearance for the VisuCon-F Low Fibrinogen Control Plasma, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Affinity Biologicals, Inc. (Ancaster, CA). The FDA issued a Cleared decision on March 6, 2016, 409 days after receiving the submission on January 22, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K150144 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2015
Decision Date March 06, 2016
Days to Decision 409 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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