510(k) Report

Devices descending from K182001

1 later device reach Acucy Influenza A&B Test with the Acucy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC20250—