510(k) Report

Devices descending from K112125

4 later devices reach Illumigene Group B Streptococcus ,External Control Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143312Portrait GBS AssayGreat Basin Corporation20150—
+1K133503Amplivue GBS AssayQuidel Corporation20131—
+1K121044Illumigene Group B Streptococcus Carrot Broth ClaimMeridian Bioscience, Inc.201201
+2K173250Solana GBS AssayQuidel Corporation20170—