Gold Standard Diagnostics

Gold Standard Diagnostics — FDA 510(k) Submissions

Gold Standard Diagnostics has submitted 14 FDA 510(k) premarket notifications since 2012, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Borrelia Serological Reagent, Helicobacter Pylori, Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, Antigens, Nontreponemal, All . Use the specialty filter in the sidebar to narrow results.