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Modification To:cobas Integra Hdl-Cholesterol Plus 2nd Generation
FDA 510(k)Class I (US FDA 510(k))
510(k) K012286
Identifiers
- 510(k) Number
- K012286 FDA 510(k)
- FDA Product Code
- LBS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1475 FDA 510(k)
- Regulation Number
- 862.1475 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Modification To:cobas Integra Hdl-Cholesterol Plus 2nd Generation by Roche Diagnostics Corp. — Class I — FDA_510K — listed in FDA 510(k)
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 | K012286 | Class I | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K012286 24 fields · synced Jun 18, 2026