510(k) Report

Devices descending from K023828

3 later devices reach K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC20250—
+1K061138Abx Pentra 400 : CRPHoriba Abx20060—
+1K050713Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set, Catalog Number…Good Biotech Corp.20050—