510(k) Report

Devices descending from K093758

2 later devices reach BGM Galectin -3 through their predicates, nearest generation first.

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