510(k) Report

Devices descending from K926221

13 later devices reach Access Ferritin Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234052Access FerritinBeckman Coulter, Inc.20240—
+1K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH201904
+1K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094—
+1K052082Ferritin on the Access Immunoassay Systems, Model 33020Beckman Coulter, Inc.200511
+1K970718Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc.199753
+2K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.201132
+2K080634Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…Beckman Coulter, Inc.20081—
+2K992188Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model…Nichols Institute Diagnostics19990—
+2K991157N Latex STFR ReagentDade Behring, Inc.19990—
+2K981208TFRRamco Laboratories, Inc.19980—
+3K240987Access sTfRBeckman Coulter, Inc.20240—
+3K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.201414
+4K192064LIAISON Vitamin B12DiaSorin, Inc.20190—