510(k) Report

Devices descending from K863821

17 later devices reach Mueller Hinton Agar W/4%Nacl and Oxacillin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092767BBL Chromagar Mrsa IIBecton, Dickinson & CO20100—
+1K082140Xpert Mrsa/SA Blood Culture AssayCepheid200832
+1K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+1K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc)20079—
+1K042812Bblchromagar MrsaBecton, Dickinson & CO200412—
+2K243625Xpert MRSA/SA SSTICepheid®20240—
+2K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+2K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid20131—
+2K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc.20111—
+2K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid201021
+2K070361MrsaselectBio-Rad20074—
+3K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…Cepheid20190—
+3K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc.20120—
+3K081212Mrsaselect - Extended IncubationBio-Rad200831
+4K171061MRSASelect IIBio-Rad201701
+4K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad20102—
+5K151688chromID MRSAbioMerieux, Inc.20160—