FDA Product Code
FDA Product Code QYT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3984
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | 2026-06-05 | Traditional | PDF ↗ |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | 2026-04-13 | Traditional | PDF ↗ |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | 2026-03-13 | Traditional | PDF ↗ |
| K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | 2025-10-12 | Traditional | PDF ↗ |
| K251753 | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | 2025-09-05 | Traditional | PDF ↗ |
| K241313 | OHC COVID-19 Antigen Self Test | Osang, LLC | 2025-05-30 | Traditional | PDF ↗ |
| K243518 | BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | 2025-02-11 | Traditional | PDF ↗ |
| K241915 | CareSuperb COVID-19 Antigen Home Test | Access Bio, Inc. | 2025-01-29 | Traditional | PDF ↗ |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 | Traditional | PDF ↗ |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K233842 | iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. | 2024-05-31 | Traditional | PDF ↗ |
| K233373 | Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. | 2024-04-19 | Traditional | PDF ↗ |
| K231795 | QuickVue COVID-19 Test | Quidel Corporation | 2024-03-22 | Traditional | PDF ↗ |
| K230828 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 2023-11-09 | Traditional | PDF ↗ |
Product code QYT · Class II · Microbiology. Data: openFDA.