510(k) Report

Devices descending from K060774

7 later devices reach Folate on the Access Immunoassay Systems, Model A14208 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223590Access Folate AssayBeckman Coulter, Inc.20230—
+1K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH201904
+1K111952Access Folate Calibrators on the Access Immunoassay Systems Model A98033Beckman Coulter, Inc.201111
+1K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094—
+2K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.201132
+3K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.201414
+4K192064LIAISON Vitamin B12DiaSorin, Inc.20190—