Opgen, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Opgen, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Acuitas AMR Gene Panel
1
Total
1
Cleared
0
Denied
Opgen, Inc. has 1 FDA 510(k) cleared medical devices. Based in Rockville, US.
Last cleared in 2021. Active since 2021. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Opgen, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Opgen, Inc.
1 devices