510(k) Report

Devices descending from K021317

13 later devices reach Triage B-Type Natriuretic Peptide (BNP) Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093758BGM Galectin -3Bg Medicine, Inc.20102—
+1K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated200641
+1K051787Triage BNP Test, Model 98000XRBiosite Incorporated20056—
+1K040437Triage Profiler S.O.B. PanelBiosite Incorporated20042—
+1K033606Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) TestAxis-Shield Diagnostics, Ltd.20041—
+1K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated20033Class I
+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
+2K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated20083Class I
+2K060964Architect BNP Assay, Model 8K28Fujirebio Diagnostics,Inc.200602
+2K042723Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated20040—
+2K042890Triage D-Dimer Test, Model 98100Biosite Incorporated20040Class I