510(k) Report

Devices descending from K092649

5 later devices reach Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.20260—
+1K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.20250—
+1K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20221—
+1K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+2K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20230—