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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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