510(k) Report

Devices descending from K043546

13 later devices reach Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160990Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation20171—
+1K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094—
+1K083339Dimension RXL Max with Advia Modular Automation System (Amas)Siemens Healthcare Diagnostics, Inc.20090—
+1K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc.200943
+2K242209UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp.20250—
+2K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.201132
+2K093318Accelerator ApsAbbott Laboratories201032
+3K213486GLP systems TrackAbbott Laboratories20221—
+3K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH201904
+3K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.201414
+3K121012Flexlab 3.6, Accelerator A3600Inpeco S.P.A.2012033
+4K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories20230—
+4K192064LIAISON Vitamin B12DiaSorin, Inc.20190—