510(k) Report

Devices descending from K953632

2 later devices reach Serim Pyloritek Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K014038Pyloritek VP Test Kit 5140VPSerim Research Corp.20020—
+1K990931EZ-HBT Helicobacter Blood TestMetabolic Solutions, Inc.19990—