510(k) Report

Devices descending from K003754

1 later device reach Immunetics C6 Lyme Elisa Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062473Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871DiaSorin, Inc.20070—