miDiagnostics HSV-1&2 CSF Test— 510(k) K250050

Substantially Equivalent

Midiagnostics NV

FDA 510(k) clearance K250050 for miDiagnostics HSV-1&2 CSF Test, Substantially Equivalent on 2025-09-30. Applicant: Midiagnostics NV.

Clearance details

Applicant: Midiagnostics NV
Product code: Code PGH
Advisory panel: Microbiology
Date received: 2025-01-10
Decision date: 2025-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

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