Illumina, Inc.

Illumina, Inc. — FDA 510(k) Submissions

Illumina, Inc. has submitted 6 FDA 510(k) premarket notifications since 2010, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection, High Throughput Dna Sequence Analyzer, Reagents For Molecular Diagnostic Test Systems, Instrumentation For Clinical Multiplex Test Systems, Test, Factor V Leiden Mutations, Genomic Dna Pcr . Use the specialty filter in the sidebar to narrow results.