510(k) Report

Devices descending from K021162

3 later devices reach Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083896Destiny Max Coagulation AnalyzerTrinity Biotech20090—
+1K082248Sta Satellite Automated Multi-Parameter AnalyzerDiagnostica Stago, Inc.200812
+2K253658STA Satellite Max®Diagnostica Stago, Inc.20260—