510(k) Report

Devices descending from K911796

2 later devices reach Immulite (TM) HCG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990222Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6Diagnostic Products Corp.199911
+2K042676Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) AssayNichols Institute Diagnostics200401