510(k) Report

Devices descending from K953366

2 later devices reach Quanta Lite Iga Aca (HRP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131821Elia (TM) Cardiolipin Iga ImmunoassayPhadia US, Inc.20131—
+2K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia AB20180—