K252283
- 510(k) number
- K252283
- Device name
- Nano-Check Influenza A+B Test
- Applicant
- Nano-Ditech Corporation NJ · US
- Product code
- PSZ — Devices Detecting Influenza A, B, And C Virus Antige
- Decision date
- 2026-01-15
- Date received
- 2025-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252283.pdf
Official FDA record: K252283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.