K251511
- 510(k) number
- K251511
- Device name
- PhenoMATRIX
- Applicant
- Copan Wasp Srl IT
- Product code
- PPU — Microbial Colony Image Assessment System
- Decision date
- 2026-01-22
- Date received
- 2025-05-16
- 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: K251511.pdf
Official FDA record: K251511
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.