510(k) Report

Devices descending from K040450

2 later devices reach Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112414Elia B2-Glycoprotein I Iga ImmunoassayPhadia US, Inc.20121—
+2K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia AB20180—