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510(k) K233842

Device
iHealth COVID-19 Antigen Rapid Test
Applicant
Ihealth Labs, Inc.
510(k) number
K233842
Product code
QYT
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-31
Date received
2023-12-04
Regulation
866.3984
Classification name
Over-The-Counter Covid-19 Antigen Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tianyang Liu
Address
880 W Maude Ave., Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QYT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC2026-06-05
K260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLC2026-04-13
K251916GenBody COVID-19 Ag Home TestGenbody.Inc.2026-03-13
K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.2025-10-12
K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.2025-09-05
K241313OHC COVID-19 Antigen Self TestOsang, LLC2025-05-30
K243518BinaxNOW™ COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.2025-02-11
K241915CareSuperb™ COVID-19 Antigen Home TestAccess Bio, Inc.2025-01-29
K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co., Ltd.2024-09-30
K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc.2024-06-21
K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc.2024-04-19
K231795QuickVue COVID-19 TestQuidel Corporation2024-03-22
K230828Flowflex COVID-19 Antigen Home TestACON Laboratories, Inc.2023-11-09