FDA 510(k) Applications for Medical Device:
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K100464 | WAKO CHEMICALS USA, INC. |
1025 TERRA BELLA AVE | MOUNTAIN VIEW | CA | 94043 |
| DEN050002 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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