510(k) Report

Devices descending from K042812

12 later devices reach Bblchromagar Mrsa 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—
+1K070361MrsaselectBio-Rad20074—
+2K243625Xpert MRSA/SA SSTICepheid®20240—
+2K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid201021
+2K081212Mrsaselect - Extended IncubationBio-Rad200831
+3K171061MRSASelect IIBio-Rad201701
+3K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid20131—
+3K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad20102—
+4K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…Cepheid20190—
+4K151688chromID MRSAbioMerieux, Inc.20160—