FDA Product Code
FDA Product Code SCA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3987
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | 2026-07-10 | Dual Track | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. | 2025-12-12 | Traditional | PDF ↗ |
| K251538 | Status COVID-19/Flu A&B | Princeton BioMeditech Corp. | 2025-11-14 | Dual Track | PDF ↗ |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | 2025-10-22 | Traditional | PDF ↗ |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | 2025-08-22 | Traditional | PDF ↗ |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. | 2025-08-20 | Traditional | PDF ↗ |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | 2025-06-17 | Dual Track | PDF ↗ |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | ACON Laboratories, Inc. | 2025-05-10 | Traditional | PDF ↗ |
| K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. | 2025-01-16 | Traditional | PDF ↗ |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC | 2025-01-13 | Traditional | PDF ↗ |
| DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen | 2024-10-07 | Direct | — |
Product code SCA · Class II · Microbiology. Data: openFDA.