Genepoc, Inc.

Genepoc, Inc. — FDA 510(k) Submissions

Genepoc, Inc. has submitted 5 FDA 510(k) premarket notifications since 2017, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, Real Time Nucleic Acid Amplification System, C. Difficile Toxin Gene Amplification Assay, Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System, System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony . Use the specialty filter in the sidebar to narrow results.