510(k) Report

Devices descending from K042389

3 later devices reach Modification to Precinorm Universal Plus and Precipath Universal Plus Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102016Precicontrol Clinchem Multi 1 and 2Roche Diagnostics20101—
+1K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH20080—
+2K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…Roche Diagnostics20130—