510(k) Report

Devices descending from K023093

7 later devices reach Access Hypersensitive HTSH Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042281Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc.20046—
+2K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH201904
+2K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc.20170—
+2K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094—
+3K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.201132
+4K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.201414
+5K192064LIAISON Vitamin B12DiaSorin, Inc.20190—