510(k) Report

Devices descending from K020348

2 later devices reach Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052407Architect Anti-Tpo Immunoassay, Calibrators & ControlsFisher Diagnostics200612
+2K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.20250—