510(k) Report

Devices descending from K151226

4 later devices reach Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20180—
+1K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20171—
+1K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20172—
+1K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20170—