510(k) Report

Devices descending from K961340

4 later devices reach Nova Lite Anca through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc.20170—
+1K072358Bioplex Vasculitis KitBio-Rad Laboratories20070—
+1K974478Immuno Concepts Anca Test SystemsImmuno Concepts, Inc.19980—
+1K974463Immuno Concepts Anca Test SystemImmuno Concepts, Inc.19980—