PhenoMATRIX
510(k) K251511
PhenoMATRIX is a Class II device made by Copan Wasp Srl, cleared under FDA 510(k) K251511 on 22 Jan 2026, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251511 | Date22 Jan 2026 | StatusActive |
Official records
- FDA 510(k) database K251511
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PPU
- Device class
- Class II
- Regulation
- 21 CFR Part 866.2190
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K251511
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PhenoMATRIX WLAB-PHENOMATRIX | WLAB-PHENOMATRIX / WLAB-PHENOMATRIX | 58059796360857 | — | On the market |