510(k) Report

Devices descending from K033415

14 later devices reach Idi-Mrsa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102740Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt)…bioMerieux, Inc.20110—
+1K091409Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727Roche Molecular Systems, Inc.20101—
+1K070462Xpert MrsaCepheid2007101
+2K142721cobas MRSA/SA TestRoche Molecular Systems, Inc.201401
+2K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.)200972
+2K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+3K243625Xpert MRSA/SA SSTICepheid®20240—
+3K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc)201244
+3K112937Mrsa/SA Elite MGBElitech20121—
+4K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc.201321
+4K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+4K132468Mrsa/SA Elite MGB, Elite MGB SoftwareElitechgroup Epoch Biosciences20130—
+5K191742ARIES MRSA AssayLuminex Corporation20190—
+5K162444Xpert MRSA NxGCepheid20160—