510(k) Report

Devices descending from K131821

1 later device reach Elia (TM) Cardiolipin Iga Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia AB20180—