510(k) Report

Devices descending from K922991

1 later device reach Abbott TDX/Tdxflx and Tdxflx Theophylline through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963673Immage Immunochemistry System TDM (Car,Phe,Phy, & the) ReagentsBeckman Instruments, Inc.19970—