510(k) K251092
- Device
- iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- Applicant
- Ihealth Labs, Inc.
- 510(k) number
- K251092
- Product code
- SCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-12
- Date received
- 2025-04-10
- Regulation
- 866.3987
- Classification name
- Multi-Analyte Respiratory Virus Antigen Detection Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Yange Wang
- Address
- 880 W Maude Ave. Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 3023372670
- 3006048451
- 3024756665
- 2246703
- 3017550662
- 3008573045
- 3005174594
- 3020885868
- 3004146366
- 3028107593
- 3016252795
- 3017662853
- 1524213
- 3008517993
- 3009238284
- 1221359
- 2531491
- 3003917514
- 3004635103
- 3016850770
Source Documents#
Other 510(k) Records For Product Code SCA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | Ihealth Labs, Inc. | 2025-12-12 |
| K251538 | Status™ COVID-19/Flu A&B | Princeton BioMeditech Corp. | 2025-11-14 |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | 2025-10-22 |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | 2025-08-22 |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. | 2025-08-20 |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | 2025-06-17 |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | ACON Laboratories, Inc. | 2025-05-10 |
| K243256 | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. | 2025-01-16 |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC | 2025-01-13 |
| DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen | 2024-10-07 |