510(k) Report

Devices descending from K032336

3 later devices reach Tina-Quant CRP (Latex) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083444C-Reactive Protein (Latex)Roche Diagnostics Corp.200921
+2K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)20200—
+2K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group201701