510(k) Report

Devices descending from K211815

2 later devices 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—
+1K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC20241—