510(k) Report

Devices descending from K030545

2 later devices reach CRP-Latex (II)X2 Seiken Assay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050836CRP Diagnostic AssaySentinel Ch. Srl20051—
+2K192118CRP VarioSENTINEL CH. SpA20190—