510(k) Report

Devices descending from P790019

3 later devices reach Havab-M Diagnostic Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093955Anti-Hav IgmRoche Diagnostics201002
+1K060770Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and ControlsOrtho-Clinical Diagnostics, Inc.20061—
+2K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.20160—