510(k) Report

Devices descending from K030286

3 later devices reach Triage Cardio Profiler/Triage Cardiac Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093758BGM Galectin -3Bg Medicine, Inc.20102—
+2K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc.20140—
+2K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag201101