Luminex Corporation

Luminex Corporation — FDA 510(k) Submissions

Luminex Corporation has submitted 14 FDA 510(k) premarket notifications since 2015, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Real Time Nucleic Acid Amplification System, Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, Bordetella Pertussis Dna Assay System, C. Difficile Toxin Gene Amplification Assay, Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System . Use the specialty filter in the sidebar to narrow results.