510(k) Report

Devices descending from K070200

2 later devices reach TDM Control Set, Model Cat# 04521536 through their predicates, nearest generation first.

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