510(k) Report

Devices descending from K040449

2 later devices reach Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091845Cardiolipin Autoantibody Immunological Test SystemPhadia US, Inc.20101—
+2K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB20160—