510(k) Report

Devices descending from K910591

11 later devices reach Roche Reagent for Total Bilirubin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060325Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…Horiba Abx20062—
+1K060574Total BilirubinAbbott Laboratories20064—
+1K050266Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory20050—
+1K022339Total BilirubinAbbott Laboratories200201
+1K981336TBILAbbott Laboratories19980—
+2K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…Elitechgroup20170—
+2K121985Architect Total BilirubinAbbott Laboratories20133—
+2K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110—
+3K223324Total Bilirubin2Abbott Ireland Diagnostics Division20220—
+3K150510Total BilirubinAbbott Laboratories20151—
+4K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.201702