510(k) Report

Devices descending from K964461

2 later devices reach One -Step Urine/Serum Combo Pregnancy Card Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123844Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…Chemtron Biotech, Inc.20130—
+1K112101Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsPolymed Therapeutics, Inc.201201