510(k) Report

Devices descending from K990222

1 later device reach Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042676Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) AssayNichols Institute Diagnostics200401