510(k) Report

Devices descending from K103557

3 later devices reach Diazyme HS CRP Assay Kit / Calibrator Set / Control Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics20171—
+1K121558Diazyme Hscrp Poc Test KitDiazyme Laboratories20120—
+2K191993Yumizen C1200 CRPHoriba Abx Sas20190—