SEKISUI Diagnostics, LLC

SEKISUI Diagnostics, LLC — FDA 510(k) Submissions

SEKISUI Diagnostics, LLC has submitted 6 FDA 510(k) premarket notifications since 2012, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Devices Detecting Influenza A, B, And C Virus Antigens, Reagent, Occult Blood, Antigens, Cf (including Cf Control), Influenza Virus A, B, C, System, Test, Infectious Mononucleosis . Use the specialty filter in the sidebar to narrow results.