FDA 510(k) Applications for Medical Device:
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093957 | FUJIREBIO DIAGNOSTICS, INC |
201 GREAT VALLEY PARKWAY | MALVERN | PA | 19355-1307 |
| K103676 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. | MALVERN | PA | 19355-1307 |
| K072939 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. | MALVERN | PA | 19355-1307 |
| K151378 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K112624 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
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