510(k) Report

Devices descending from K961114

2 later devices reach Ast Incorporating DST through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992801Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast…Sigma Diagnostics, Inc.19990—
+1K980666Infinity Ast Reagent (Procedure NO. 51)Sigma Diagnostics, Inc.19980—