510(k) Report

Devices descending from K042281

6 later devices reach Modification to Access Hypersensitive HTSH Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH201904
+1K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc.20170—
+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—