510(k) Report

Devices descending from K100024

4 later devices reach Teco Diagnostics Uti Detection Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231045Healgen URS Test StripsHealgen Scientific,, LLC20233—
+2K251800Healgen® URS Test StripsHealgen Scientific,, LLC20250—
+2K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.20250—
+2K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.20250—