510(k) Report

Devices descending from K121985

3 later devices reach Architect Total Bilirubin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223324Total Bilirubin2Abbott Ireland Diagnostics Division20220—
+1K150510Total BilirubinAbbott Laboratories20151—
+2K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.201702