Mrl Diagnostics

Mrl Diagnostics — FDA 510(k) Submissions

Mrl Diagnostics has submitted 7 FDA 510(k) premarket notifications since 1994, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Borrelia Serological Reagent, Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific, Antibody Igm, If, Epstein-barr Virus, Test, Antigen, Nuclear, Epstein-barr Virus, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 . Use the specialty filter in the sidebar to narrow results.