FDA Product Code
FDA Product Code ONX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 866.6050
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | 2016-06-15 | Traditional | PDF ↗ |
| K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | 2016-05-16 | Traditional | PDF ↗ |
| K151502 | ARCHITECT ROMA | Fujirebio Diagnostics,Inc. | 2016-04-28 | Traditional | PDF ↗ |
| K150588 | OVA1 Next Generation | Vermillion, Inc. | 2016-03-18 | Traditional | PDF ↗ |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Fujirebio Diagnostics,Inc. | 2011-09-01 | Traditional | PDF ↗ |
| DEN090004 | OVA1 TEST | Vermillion | 2009-09-11 | Post-NSE | — |
Product code ONX · Class II · Obstetrics/Gynecology. Data: openFDA.