PhenoMATRIX— 510(k) K251511

Substantially Equivalent

Copan Wasp Srl

FDA 510(k) clearance K251511 for PhenoMATRIX, Substantially Equivalent on 2026-01-22. Applicant: Copan Wasp Srl. Device class: 2.

Clearance details

Applicant: Copan Wasp Srl
Product code: Code PPU
Device class: Class 2
Regulation: 21 CFR 866.2190
Advisory panel: Microbiology
Date received: 2025-05-16
Decision date: 2026-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brescia, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Copan Wasp Srl

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