510(k) Report

Devices descending from K941840

2 later devices reach Hemagen Acl Iga Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992241Virgo B2 Glycoprotein I Iga Antibody KitHemagen Diagnostics, Inc.19990—
+1K971039Hemagen Anti Cardiolipin ScreenHemagen Diagnostics, Inc.19970—