 ROCKVILLE, Md., June 07, 2021 GLOBE NEWSWIRE -- OpGen, Inc. Nasdaq: OPGN, OpGen, a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that it has submitted an updated 510k summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates. This document incorporates all of the FDAs requested updates to various key documents such as the Package Insert, Electronic User Guide, and Operator Manual. Consistent with the FDAs previously communicated timeline, the FDA provided substantive feedback on all of these key documents by the end of May. The FDA previously informed OpGen that it intends to complete its review by the end of August 2021, but that it cannot commit to a timeline and that such timeline can be affected by various factors, including the FDAs other workload and public health priorities. 