K250398
- 510(k) number
- K250398
- Device name
- Innovita Flu A/B Antigen Rapid Test
- Applicant
- Innovita (Tangshan) Biological Technology Co., Ltd. CN
- Product code
- PSZ — Devices Detecting Influenza A, B, And C Virus Antige
- Decision date
- 2025-07-03
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250398.pdf
Official FDA record: K250398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.