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

Name: FDA 510(k) clearance K250050
Creator: U.S. Food and Drug Administration
Published: 2025-09-30

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. Device class: 2.

Clearance details

Applicant: Midiagnostics NV
Product code: Code PGH
Device class: Class 2
Regulation: 21 CFR 866.3307
Advisory panel: Microbiology
Date received: 2025-01-10
Decision date: 2025-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PGH

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K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK2014-07-01
DEN130049 — SIMPLEXA HSV 1&2 DIRECT2014-03-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.