510(k) Report

Devices descending from K000121

9 later devices reach Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013128N Latex LP (a)Dade Behring, Inc.20027—
+1K013126N LP (a) Standard SYDade Behring, Inc.20010—
+2K050487Quantia LA (a)Biokit, S.A.20051—
+2K030477Diadexus Plac TestDiadexus, Inc.200342
+3K141575Plac Test for LP-PLA2 ActivityDiadexus, Inc.20140—
+3K132400LP (a) Calibrators, and LP (a) ControlsBiokit, S.A.20130—
+3K050029Cardiompo TestPrognostix, Inc.20052—
+4K071474Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control…Siemens Healthcare Diagnostics20080—
+4K062840Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated20070—