K250050
- 510(k) number
- K250050
- Device name
- miDiagnostics HSV-1&2 CSF Test
- Applicant
- Midiagnostics NV BE
- Product code
- PGH — Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Decision date
- 2025-09-30
- Date received
- 2025-01-10
- 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: K250050.pdf
Official FDA record: K250050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.