510(k) Report

Devices descending from K003597

1 later device reach Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121533ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…Tosoh Bioscience, Inc.201202