510(k) Report

Devices descending from K080183

1 later device reach Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090939Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…Roche Diagnostics20090—