Nanosphere, Inc.

Nanosphere, Inc. — FDA 510(k) Submissions

Nanosphere, Inc. has submitted 16 FDA 510(k) premarket notifications since 2007, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Respiratory Virus Panel Nucleic Acid Assay System, Gram-positive Bacteria And Their Resistance Markers, System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, Drug Metabolizing Enzyme Genotyping Systems . Use the specialty filter in the sidebar to narrow results.