The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Roma (he4 Eia + Architect Ca 125 Ii).
| Device ID | K103358 |
| 510k Number | K103358 |
| Device Name: | ROMA (HE4 EIA + ARCHITECT CA 125 II) |
| Classification | Ovarian Adnexal Mass Assessment Score Test System |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Diana L Dickson |
| Correspondent | Diana L Dickson FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | ONX |
| CFR Regulation Number | 866.6050 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2011-09-01 |
| Summary: | summary |