510(k) Report

Devices descending from K990431

2 later devices reach Aia-Pack CA 125 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023891ST Aia-Pack CA 125 Enzyme ImmunoassayTosoh Medics, Inc.20021—
+2K080561Vidas CA 125 II AssaybioMerieux, Inc.20090—