510(k) Report

Devices descending from K063329

4 later devices reach Abbott Architect Havab-M through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251995Access anti-HAV IgMBeckman Coulter, Inc.20261—
+1K113704Architect Havab-GAbbott Laboratories201212
+2K260048Elecsys Anti-HAV IgMRoche Diagnostics20260—
+2K222850HAVAb IgG IIAbbott Laboratories20230—