510(k) Report

Devices descending from K932127

2 later devices reach TDX/Tdxflx & Tdxflx Theophylline Monoclonal II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972495Accumeter Theophylline TestChemtrak, Inc.19970—
+1K962294Immage Immunochemistry SystemBeckman Instruments, Inc.199602