510(k) Report

Devices descending from K052301

2 later devices reach Fastpack TSH Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123725Fastpack Control KitQualigen, Inc.20130—
+1K110761Mict TSHMagnabiosciences, LLC20120—