510(k) Report

Devices descending from K013128

7 later devices reach N Latex LP (a) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050487Quantia LA (a)Biokit, S.A.20051—
+1K030477Diadexus Plac TestDiadexus, Inc.200342
+2K141575Plac Test for LP-PLA2 ActivityDiadexus, Inc.20140—
+2K132400LP (a) Calibrators, and LP (a) ControlsBiokit, S.A.20130—
+2K050029Cardiompo TestPrognostix, Inc.20052—
+3K071474Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control…Siemens Healthcare Diagnostics20080—
+3K062840Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated20070—