510(k) Report

Devices descending from K000196

5 later devices reach Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021229Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…Beckman Coulter, Inc.200231
+1K012040Ramp Myoglobin AssayResponse Biomedical Corp.20010—
+2K231832Access MyoglobinBeckman Coulter, Inc.20230—
+2K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc.20090—
+2K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—