Cleared Traditional

K110432 - VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
(FDA 510(k) Clearance)

K110432 · Affinity Biologicals, Inc. · Hematology

Oct 2011

Decision

247d

Days

Class 2

Risk

K110432 is an FDA 510(k) clearance for the VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN. This device is classified as a Plasma, Coagulation Control (Class II — Special Controls, product code GGN).

Submitted by Affinity Biologicals, Inc. (Ancaster, Ontario, CA). The FDA issued a Cleared decision on October 20, 2011, 247 days after receiving the submission on February 15, 2011.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K110432 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2011
Decision Date	October 20, 2011
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF