510(k) Report

Devices descending from K241324

1 later device reach LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC20250—