510(k) Report

Devices descending from K942566

3 later devices reach Imx Ultrasensistive HTSH II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052301Fastpack TSH ImmunoassayQualigen, Inc.200621
+2K123725Fastpack Control KitQualigen, Inc.20130—
+2K110761Mict TSHMagnabiosciences, LLC20120—