Panels › Obstetrics/Gynecology › Product code ONX · Class 2
Ovarian Adnexal Mass Assessment Score Test System
Regulation 866.6050
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ONX
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 3 | 0 |
| Vermillion | 2 | 0 |
| Roche Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2016 | K153607 | ROMA Calculation Tool Using Elecsys Assays Roche Diagnostics | ONX |
| May 16, 2016 | K160090 | Lumipulse G ROMA Fujirebio Diagnostics,Inc. | ONX |
| Apr 28, 2016 | K151502 | ARCHITECT ROMA Fujirebio Diagnostics,Inc. | ONX |
| Mar 18, 2016 | K150588 | OVA1 Next Generation Vermillion, Inc. | ONX |
| Sep 1, 2011 | K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) Fujirebio Diagnostics,Inc. | ONX |
| Sep 11, 2009 | DEN090004 | OVA1 TEST Vermillion | ONX |
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