510(k) Report

Devices descending from K962890

2 later devices reach Cholesterol-Incorporating Dynamic Stab Tech (DST) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992803Sigma Diagnostics Infinity Cholesterol Reagent, Models 401-25, 401-100P, 401-500P…Sigma Diagnostics, Inc.19990—
+1K980667Infinity Cholesterol Reagent (Procedure NO. 401)Sigma Diagnostics, Inc.19980—