510(k) K250050 ยท PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
miDiagnostics HSV-1&2 CSF Test
| Applicant | Midiagnostics NV, Leuven, BE |
| Decision | Substantially Equivalent, Sep 30, 2025 |
| Received | Jan 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250050
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.