510(k) Report

Devices descending from K904226

8 later devices reach 'Tdxflx Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060709Multigent GentamicinSeradyn, Inc.20060—
+1K013959Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur AnalyzersBayer Diagnostics Corp.20020—
+1K964009Immage Immunochemistry System Gentamicin (Gen)/Tobramycin (Tob) Reagent / Beckman Drug…Beckman Instruments, Inc.19970—
+1K963673Immage Immunochemistry System TDM (Car,Phe,Phy, & the) ReagentsBeckman Instruments, Inc.19970—
+1K962519Emit 2000 Gentamicin Assay and CalibratorsBehring Diagnostics, Inc.19961—
+1K961256Synchron Systems Valproic Acid (Vpa) ReagentBeckman Instruments, Inc.19961—
+2K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc.200501
+2K031870Synchron Systems Valproic Acid (V-PA) ReagentBeckman Coulter, Inc.20030—