510(k) Report

Devices descending from K992658

2 later devices reach Osom Ultra Strep a Test, Model 147 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091489Clearview Advanced Strep a , Model 737-430Binax, Inc.20091—
+2K122718BD Veritor (TM) System for Rapid Detection of Group a StrepBecton, Dickinson and Company20130—