Helix Opco, LLC

Helix Opco, LLC — FDA 510(k) Submissions

Helix Opco, LLC has submitted 2 FDA 510(k) premarket notifications since 2020, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Whole Exome Sequencing Constituent Device, Genetic Variant Detection And Health Risk Assessment System . Use the specialty filter in the sidebar to narrow results.