510(k) Report

Devices descending from K930454

2 later devices reach Boehringer Mannheim Coaguchek System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994349Coaguchek S System, Model 2138280Roche Diagnostics Corp.200013
+2K071265Smartcheck Inr SystemInverness Medical Innovations, Inc.20070—