510(k) Report

Devices descending from K946067

1 later device reach Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…Wako Chemicals USA, Inc.20080—