FDA 510(k) Applications for Medical Device:
Ovarian Adnexal Mass Assessment Score Test System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K151502 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K160090 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K103358 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. | MALVERN | PA | 19355-1307 |
| K153607 | ROCHE DIAGNOSTICS |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| DEN090004 | VERMILLION |
47350 FREMONT BLVD. | FREMONT | CA | 94538 |
| K150588 | VERMILLION, INC. |
12117 BEE CAVES RD., BLDG III, SUITE 100 | AUSTIN | TX | 78738 |
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