510(k) Report

Devices descending from K060429

3 later devices reach TDM Control Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070200TDM Control Set, Model Cat# 04521536Roche Diagnostics Corp.20072—
+2K080183Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000…Roche Diagnostics Corp.20081—
+3K090939Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…Roche Diagnostics20090—