510(k) K243518
- Device
- BinaxNOW™ COVID-19 Antigen Self Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- 510(k) number
- K243518
- Product code
- QYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-11
- Date received
- 2024-11-13
- Regulation
- 866.3984
- Classification name
- Over-The-Counter Covid-19 Antigen Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kristen Cyr
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 3024756665
- 3021090658
- 3007606081
- 3017550662
- 3031823359
- 3008573045
- 1528450
- 3020885868
- 3004146366
- 3028107593
- 3017662853
- 9615507
- 3032171519
- 3008517993
- 3009238284
- 2531491
- 3033751096
- 3013160357
- 3004635103
- 3014660585
- 3032562
- 3023322455
Source Documents#
Other 510(k) Records For Product Code QYT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | 2026-04-13 |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | 2026-03-13 |
| K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | 2025-10-12 |
| K251753 | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | 2025-09-05 |
| K241313 | OHC COVID-19 Antigen Self Test | Osang, LLC | 2025-05-30 |
| K241915 | CareSuperb™ COVID-19 Antigen Home Test | Access Bio, Inc. | 2025-01-29 |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | 2024-06-21 |
| K233842 | iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. | 2024-05-31 |
| K233373 | Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. | 2024-04-19 |
| K231795 | QuickVue COVID-19 Test | Quidel Corporation | 2024-03-22 |
| K230828 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 2023-11-09 |