Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc. — FDA 510(k) Submissions

Roche Molecular Systems, Inc. has submitted 49 FDA 510(k) premarket notifications since 1993, of which 46 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dna-reagents, Neisseria, Dna Probe, Nucleic Acid Amplification, Chlamydia, C. Difficile Toxin Gene Amplification Assay, Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections, Respiratory Virus Panel Nucleic Acid Assay System . Use the specialty filter in the sidebar to narrow results.