510(k) Report

Devices descending from K971349

4 later devices reach Biosign Strep a - Direct Strep a Antigen Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040708Status First Strep aPrinceton BioMeditech Corp.20043—
+2K133343Wondfo Rapid Strep a TestGuangzhou Wondfo Biotech Co., Ltd.20142—
+3K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.20260—
+3K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC20220—