FDA 510(k) Applications for Medical Device Product Code "PMY"

FDA 510(k) Number Applicant Device Name Decision Date
K152614 CEPHEID Xpert Carba-R 03/07/2016
K190275 GenePOC Inc. GenePOC Carba 05/10/2019
K191288 OpGen, Inc. Acuitas AMR Gene Panel 09/30/2021


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