K251538
- 510(k) number
- K251538
- Device name
- Status COVID-19/Flu A&B
- Applicant
- Princeton BioMeditech Corp. NJ · US
- Product code
- SCA — Multi-Analyte Respiratory Virus Antigen Detection Te
- Decision date
- 2025-11-14
- Date received
- 2025-05-19
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251538.pdf
Official FDA record: K251538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.