510(k) Report

Devices descending from K970718

5 later devices reach Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080634Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…Beckman Coulter, Inc.20081—
+1K992188Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model…Nichols Institute Diagnostics19990—
+1K991157N Latex STFR ReagentDade Behring, Inc.19990—
+1K981208TFRRamco Laboratories, Inc.19980—
+2K240987Access sTfRBeckman Coulter, Inc.20240—