FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
PhenoMATRIX
K Number: K251511
·
Decision Jan 22, 2026
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
5
Review Days
251
Basic Information
- Device Name
- PhenoMATRIX
- K Number
- K251511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2190
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Copan Wasp Srl
- Date Received
- May 16, 2025
- Decision Date
- January 22, 2026
- Product Code
- PPU
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PPU | Microbial Colony Image Assessment System | FDA class 2 | Microbiology |
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