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FDA 510(k) Applications for Medical Device Product Code "PEU"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN130032
CEPHEID
XPERT MTB/RIF ASSAY
07/25/2013
K143302
CEPHEID
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
02/12/2015
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