510(k) Report

Devices descending from K153165

2 later devices reach NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171482NEPHROCHECK Test SystemAstute Medical, Inc.20171—
+2K210793Vidas NephrocheckBiomérieux SA20220—