510(k) Report

Devices descending from K093346

7 later devices reach BD Geneohm Mrsa Acp Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc)201244
+1K112937Mrsa/SA Elite MGBElitech20121—
+2K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc.201321
+2K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+2K132468Mrsa/SA Elite MGB, Elite MGB SoftwareElitechgroup Epoch Biosciences20130—
+3K191742ARIES MRSA AssayLuminex Corporation20190—
+3K162444Xpert MRSA NxGCepheid20160—