510(k) Report

Devices descending from K050944

3 later devices reach K-Assay Ferritin (2) & Ferritin Calibrator Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc.20121—
+1K121232K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorKamiya Biomedical Company20120—
+2K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130—