510(k) K251511
- Device
- PhenoMATRIX
- Applicant
- Copan Wasp Srl
- 510(k) number
- K251511
- Product code
- PPU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-22
- Date received
- 2025-05-16
- Regulation
- 866.2190
- Classification name
- Microbial Colony Image Assessment System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chiara Congiu
- Address
- Via Achille Grandi, 32 Brescia IT 25125 25125
FDA Registration Numbers#
- 3009288740
- 3011637800
- 3023339158