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TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315 - Integra Catalog # 2148323
FDA 510(k)Class II (US FDA 510(k))
510(k) K003064
Identifiers
- 510(k) Number
- K003064 FDA 510(k)
- FDA Product Code
- DDG FDA 510(k)
- Models / Variants
- Integra Catalog # 2148323 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5880 FDA 510(k)
- Regulation Number
- 866.5880 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315 - Integra Catalog # 2148323 by Roche Diagnostics Corp. — Class II — FDA_510K…
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 | K003064 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K003064 24 fields · synced Jun 18, 2026