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Randox Csf Controls Levels 2 And 3
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K132156
Identifiers
- 510(k) Number
- K132156 FDA 510(k)
- FDA Product Code
- JJY FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1660 FDA 510(k)
- Regulation Number
- 862.1660 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Randox Csf Controls Levels 2 And 3 by Randox Laboratories, Ltd. — Class I — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
IVDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K132156 | Class I | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA 510(k) K132156 24 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 19, 2026