510(k) Report

Devices descending from K920372

2 later devices reach Acs Total Ige Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.20200—
+1K103548Advia Centaur Calibarator 80 Model 10492491Siemens Healthcare Diagnostics, Inc.20110—