FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Methotrexate
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K163359 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K232017 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K111904 | ARK DIAGNOSTICS,INC |
1190 BORDEAUX DRIVE | SUNNYVALE | CA | 94089 |
| K233454 | Roche Diagnostics Operations |
9115 Hague Road | Indianapolis | IN | 46250 |
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