510(k) Report

Devices descending from K922823

16 later devices reach Access Theophylline Immunoassay Reagents through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121214Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…Beckman Coulter, Inc.201385
+1K023764Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc.2003631
+2K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.202504
+2K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.2022018
+2K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH201904
+2K172787Access hsTnlBeckman Coulter, Inc.201841
+2K172783Access hs TnlBeckman Coulter, Inc.201802
+2K121790Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay…Beckman Coulter, Inc.201305
+2K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094—
+3K222881Access hsTnIBeckman Coulter, Inc.202301
+3K230648Access hsTnIBeckman Coulter, Inc.202321
+3K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.201132
+4K243483Access hsTnIBeckman Coulter, Inc.20250—
+4K242870Access hsTnIBeckman Coulter, Inc.20250—
+4K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.201414
+5K192064LIAISON Vitamin B12DiaSorin, Inc.20190—