K233358
- 510(k) number
- K233358
- Device name
- SCoV-2 Ag Detect Rapid Test
- Applicant
- InBios International, Inc. WA · US
- Product code
- QVF — Simple Point-Of-Care Device To Directly Detect Sars-
- Decision date
- 2024-08-23
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.