510(k) Report

Devices descending from K910593

6 later devices reach Roche Reagent for Direct Bilirubin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060325Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…Horiba Abx20062—
+1K050266Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory20050—
+1K991175Modification to Alcyon Direct BilirubinAbbott Laboratories19990—
+1K981222Direct Bilirubin (Dbil)Abbott Laboratories19980—
+2K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…Elitechgroup20170—
+2K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110—