510(k) Report

Devices descending from K882233

9 later devices reach TDX (R) Digoxin NXT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983151Immage Immunochemistry System Digoxin (Dig) ReagentBeckman Coulter, Inc.19980—
+1K982935Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug CalibratorBeckman Coulter, Inc.19981—
+1K973112Elecsys DigoxinBoehringer Mannheim Corp.19971—
+1K970883Cedia Digoxin IIBoehringer Mannheim Corp.19970—
+1K970881Cedia DigoxinBoehringer Mannheim Corp.19970—
+1K963062Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2Beckman Instruments, Inc.19960—
+1K962294Immage Immunochemistry SystemBeckman Instruments, Inc.199602
+2K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+2K993473Synchron Systems Drug Calibrator 2Beckman Coulter, Inc.19990—