510(k) Report

Devices descending from K051787

6 later devices reach Triage BNP Test, Model 98000XR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093758BGM Galectin -3Bg Medicine, Inc.20102—
+1K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated20083Class I
+1K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated200641
+2K252169Access BNP IIBeckman Coulter, Inc.20260—
+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