Panther Fusion GBS Assay
Jul 2018
87d
Diagenode
1
Total
1
Cleared
0
Denied
Diagenode — FDA 510(k) Submissions
Diagenode has submitted 1 FDA 510(k) premarket notifications since 2018, of which 1 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 . Use the specialty filter in the sidebar to narrow results.
1 devices