510(k) Report

Devices descending from K990578

2 later devices reach Osom Card II HCG-Urine Test, Model 102 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131931Chemtrue (R) HCG Pregnancy Urine Midstream TestChemtron Biotech, Inc.20130—
+1K123844Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…Chemtron Biotech, Inc.20130—