510(k) Report

Devices descending from K953383

3 later devices reach Wyntek Osom HCG-Urine Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984076Instant-View Pregnancy Urine TestAlfa Scientific Designs, Inc.19990—
+1K984079Instant-View Pregnancy Urine Dip-Strip TestAlfa Scientific Designs, Inc.19990—
+1K962906Scripps Laboratories HCG One-StepScripps Laboratories, Inc.19960—