Focus Diagnostics, Inc.

Focus Diagnostics, Inc. — FDA 510(k) Submissions

Focus Diagnostics, Inc. has submitted 14 FDA 510(k) premarket notifications since 2007, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, Respiratory Virus Panel Nucleic Acid Assay System, Anti-jcv Antibody Detection Assay, Antibody Igm, If, Epstein-barr Virus, Epstein-barr Virus, Other . Use the specialty filter in the sidebar to narrow results.