510(k) Report

Devices descending from K020758

2 later devices reach Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696 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—