510(k) Report

Devices descending from K130894

1 later device reach Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…Cepheid20190—