PhenoMATRIX
FDA 510(k) clearance K251511 · decided 2026-01-22
Clearance details
- K-number
- K251511
- Device name
- PhenoMATRIX
- Applicant
- Copan Wasp Srl
- Decision
- Substantially Equivalent
- Date received
- 2025-05-16
- Decision date
- 2026-01-22
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- PPU
- Device class
- 2
- Regulation number
- 866.2190
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Brescia, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APAS Independence with Urine Analysis Module (K183648) | Clever Culture Systems AG | 2019-05-15 |
| APAS Compact with Urine Analysis Module (DEN150059) | Clever Culture Systems AG | 2016-10-06 |
Recalls involving this device
No recalls on record reference this clearance.