Genmark Diagnostics, Incorporated

Genmark Diagnostics, Incorporated — FDA 510(k) Submissions

Genmark Diagnostics, Incorporated has submitted 7 FDA 510(k) premarket notifications since 2016, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gram-negative Bacteria And Associated Resistance Markers, Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System, Respiratory Virus Panel Nucleic Acid Assay System, Instrumentation For Clinical Multiplex Test Systems, Gram-positive Bacteria And Their Resistance Markers . Use the specialty filter in the sidebar to narrow results.