510(k) Report

Devices descending from K120138

4 later devices reach BD Max Mrsa Assay, BD Max Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc.201321
+1K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+2K191742ARIES MRSA AssayLuminex Corporation20190—
+2K162444Xpert MRSA NxGCepheid20160—