510(k) Report

Devices descending from K200133

1 later device reach hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…Anhui Deepblue Medical Technology Co., Ltd.20240—