510(k) Report

Devices descending from K855221

2 later devices reach Seratest RF (Hemagglutination) Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970373Raichem Rheumatoid Factor SpiaHenage Diagnostics, Inc.19970—
+1K962836Hemagen Rheumatoid Factor Kit (Eia Method)Hemagen Diagnostics, Inc.19960—