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ROMA Calculation Tool Using Elecsys Assays
FDA 510(k)Class II (US FDA 510(k))
510(k) K153607
Identifiers
- 510(k) Number
- K153607 FDA 510(k)
- FDA Product Code
- ONX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6050 FDA 510(k)
- Regulation Number
- 866.6050 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ROMA Calculation Tool Using Elecsys Assays by Roche Diagnostics — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153607 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K153607 24 fields · synced Jun 18, 2026