510(k) Report

Devices descending from K120413

3 later devices reach Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161220ARIES® Flu A/B & RSV AssayLuminex Corporation201601
+1K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackFocus Diagnostics20141—
+2K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackFocus Diagnostics, Inc.201501