510(k) Report

Devices descending from K133343

2 later devices reach Wondfo Rapid Strep a Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.20260—
+1K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC20220—