510(k) Report

Devices descending from K041799

2 later devices reach Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc.20150—
+1K042838Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…Ortho-Clinical Diagnostics, Inc.20040—