The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Roma.
| Device ID | K151502 |
| 510k Number | K151502 |
| Device Name: | ARCHITECT ROMA |
| Classification | Ovarian Adnexal Mass Assessment Score Test System |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Diana Dickson |
| Correspondent | Diana Dickson Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Product Code | ONX |
| CFR Regulation Number | 866.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2016-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740138738 | K151502 | 000 |
| 00380740146269 | K151502 | 000 |