Vysis

Vysis — FDA 510(k) Submissions

Vysis has submitted 9 FDA 510(k) premarket notifications since 1996, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dna-probe Kit, Human Chromosome, System, Test, Tumor Marker, Monitoring, Bladder, System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays, Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment, Chronic Lymphocytic Leukemia Fish Probe Kit . Use the specialty filter in the sidebar to narrow results.