510(k) Report

Devices descending from K993107

4 later devices reach Bio-Rad Homocysteine by HPLC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc.200611
+1K030754A/C Enzymatic Homocysteine AssayAnticancer, Inc.20031—
+2K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20130—
+2K080851A/C Portable Enzymatic Homocysteine AssayAnticancer, Inc.20080—