510(k) Report

Devices descending from K021229

3 later devices reach Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231832Access MyoglobinBeckman Coulter, Inc.20230—
+1K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc.20090—
+1K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—