510(k) Report

Devices descending from K230828

10 later devices reach Flowflex COVID-19 Antigen Home Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC20260—
+1K241313OHC COVID-19 Antigen Self TestOsang, LLC20251—
+1K241915CareSuperb™ COVID-19 Antigen Home TestAccess Bio, Inc.20250—
+1K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co., Ltd.20240—
+1K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc.20241—
+1K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc.20240—
+1K231795QuickVue COVID-19 TestQuidel Corporation20241—
+2K260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLC20260—
+2K251916GenBody COVID-19 Ag Home TestGenbody.Inc.20260—
+2K243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.20250—