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Tina-Quant Apolipoprotein A-1 Ver.2
FDA 510(k)Class I (US FDA 510(k))
510(k) K013278
Identifiers
- 510(k) Number
- K013278 FDA 510(k)
- FDA Product Code
- DEL FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5590 FDA 510(k)
- Regulation Number
- 866.5590 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Tina-Quant Apolipoprotein A-1 Ver.2 by Roche Diagnostics Corp. — Class I — 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 | K013278 | Class I | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K013278 24 fields · synced Jun 18, 2026