The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roma Calculation Tool Using Elecsys Assays.
| Device ID | K153607 |
| 510k Number | K153607 |
| Device Name: | ROMA Calculation Tool Using Elecsys Assays |
| Classification | Ovarian Adnexal Mass Assessment Score Test System |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | ONX |
| CFR Regulation Number | 866.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702702127 | K153607 | 000 |