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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 481 Edward H. Ross Drive, Elmwood Park, NJ, 07407
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003652672
- DUNS Number
- —
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 4Kscore Test | 1 | FDA UDI | Class III | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 31, 2023 | Z-0516-2024 | — | open, classified | Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test. |
| Nov 18, 2022 | Z-1676-2023 | — | open, classified | SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results |