Panels › Microbiology › Product code QYT · Class 2
Over-The-Counter Covid-19 Antigen Test
Regulation 866.3984
3510(k)s in 12 months (14 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in QYT
| Company | 510(k)s | Recalls |
|---|---|---|
| FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD | 0 | 3 |
| ACON Laboratories, Inc. | 2 | 0 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 0 |
| Access Bio, Inc. | 1 | 0 |
| Assure Tech., LLC | 1 | 0 |
| CorDx, Inc. | 1 | 0 |
| Genabio Diagnostics, Inc. | 1 | 0 |
| Genbody.Inc. | 1 | 0 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 0 |
| Healgen Scientific,, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2026 | K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test Assure Tech., LLC | QYT |
| Apr 13, 2026 | K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test Healgen Scientific,, LLC | QYT |
| Mar 13, 2026 | K251916 | GenBody COVID-19 Ag Home Test Genbody.Inc., KR | QYT |
| Oct 12, 2025 | K251595 | COVID-19 Detect Rapid Self -Test InBios International, Inc. | QYT |
| Sep 5, 2025 | K251753 | GenaCheck COVID-19 Rapid Self-Test Genabio Diagnostics, Inc. | QYT |
| May 30, 2025 | K241313 | OHC COVID-19 Antigen Self Test Osang, LLC | QYT |
| Feb 11, 2025 | K243518 | BinaxNOW COVID-19 Antigen Self Test Abbott Diagnostics Scarborough, Inc. | QYT |
| Jan 29, 2025 | K241915 | CareSuperb COVID-19 Antigen Home Test Access Bio, Inc. | QYT |
| Sep 30, 2024 | K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd., CN | QYT |
| Jun 21, 2024 | K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test CorDx, Inc. | QYT |
| May 31, 2024 | K233842 | iHealth COVID-19 Antigen Rapid Test Ihealth Labs, Inc. | QYT |
| Apr 19, 2024 | K233373 | Flowflex® Plus COVID-19 Home Test ACON Laboratories, Inc. | QYT |
| Mar 22, 2024 | K231795 | QuickVue COVID-19 Test Quidel Corporation | QYT |
| Nov 9, 2023 | K230828 | Flowflex COVID-19 Antigen Home Test ACON Laboratories, Inc. | QYT |
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