510(k) Report

Devices descending from K231045

3 later devices reach Healgen URS Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251800Healgen® URS Test StripsHealgen Scientific,, LLC20250—
+1K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.20250—
+1K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.20250—