510(k) Report

Devices descending from K231187

4 later devices reach Nano-Check™ COVID-19 Antigen Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.20260—
+1K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.20250—
+1K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and Company20250—
+1K250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.20250—