Medical Device Manufacturer · CA , Ancaster, Ontario

Affinity Biologicals, Inc.

5 submissions · 5 cleared · Since 2005

Total

Cleared

Denied

Affinity Biologicals, Inc. — FDA 510(k) Submissions

Affinity Biologicals, Inc. has submitted 5 FDA 510(k) premarket notifications since 2005, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plasma, Coagulation Control, Test, Qualitative And Quantitative Factor Deficiency . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

VisuCon-F Low Fibrinogen Control Plasma

K150144 · GGN Plasma, Coagulation Control · Hematology

Mar 2016 409d

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

K110432 · GGN Plasma, Coagulation Control · Hematology

Oct 2011 247d

VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA

K091284 · GGN Plasma, Coagulation Control · Hematology

Oct 2009 180d

VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG

K052825 · GGP Test, Qualitative And... · Hematology

Jan 2006 107d

VISULIZE FACTOR IX ANTIGEN KIT

K051054 · GGP Test, Qualitative And... · Hematology

Jun 2005 64d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Affinity Biologicals, Inc.

Affinity Biologicals, Inc. — FDA 510(k) Submissions

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