510(k) K233358
- Device
- SCoV-2 Ag Detect Rapid Test
- Applicant
- InBios International, Inc.
- 510(k) number
- K233358
- Product code
- QVF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-23
- Date received
- 2023-09-29
- Regulation
- 866.3982
- Classification name
- Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Dual Track
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Annabel Tsai
- Address
- 307 Westlake Ave. N, Suite 300 Seattle WA US 98109 98109
FDA Registration Numbers#
- 3006948883
- 3004635103
- 3007886372
- 2024674
- 3033507883
- 1119779
- 3008517993
- 3021090658
- 3009238284
- 3007606081
- 3002792284
- 3032562
- 2030538
- 3033751096
- 3005174594
- 3023322455
- 3026664926
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QVF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 |
| K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | 2025-06-16 |
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC | 2024-04-19 |
| K231187 | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | 2024-01-23 |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023-12-13 |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023-03-08 |