510(k) Report

Devices descending from K973126

10 later devices reach Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040437Triage Profiler S.O.B. PanelBiosite Incorporated20042—
+1K033747Ramp CK-MB AssayResponse Biomedical Corp.20040—
+1K033745Ramp Troponin I AssayResponse Biomedical Corp.20040—
+1K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated20033Class I
+1K012040Ramp Myoglobin AssayResponse Biomedical Corp.20010—
+2K093758BGM Galectin -3Bg Medicine, Inc.20102—
+2K042723Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated20040—
+2K042890Triage D-Dimer Test, Model 98100Biosite Incorporated20040Class I
+3K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc.20140—
+3K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag201101