FDA.reportPublic FDA data

510(k) DEN240029

Device
Healgen Rapid Check COVID-19/Flu A&B Antigen Test
Applicant
Healgen
510(k) number
DEN240029
Product code
SCA
Decision
Unknown (DENG)
Decision date
2024-10-07
Date received
2024-06-07
Regulation
866.3987
Classification name
Multi-Analyte Respiratory Virus Antigen Detection Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Bingliang Fang
Address
3818 Fuqua St. Houston TX US 77047 77047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code SCA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.2025-12-12
K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc.2025-12-12
K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp.2025-11-14
K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc.2025-10-22
K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.2025-08-22
K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.2025-08-20
K243561Nano-Check Influenza+COVID-19 Dual TestNano-Ditech Corporation2025-06-17
K250377Flowflex Plus COVID-19 + Flu A/B Home TestACON Laboratories, Inc.2025-05-10
K243256WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTestWondfo USA Co, Ltd.2025-01-16
K243262QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestOsang, LLC2025-01-13