510(k) Report

Devices descending from K040708

3 later devices reach Status First Strep a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133343Wondfo Rapid Strep a TestGuangzhou Wondfo Biotech Co., Ltd.20142—
+2K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.20260—
+2K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC20220—