510(k) Report

Devices descending from K993108

2 later devices reach Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083188Varelisa Recombi Ana Screen, Model 12 596Phadia US, Inc.20090—
+1K050967Varelisa Recombi CTD Screen, Model 13096Sweden Diagnostics (Germany) GmbH20050—