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Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-Level
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K072257
Identifiers
- 510(k) Number
- K072257 FDA 510(k)
- FDA Product Code
- LAS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3280 FDA 510(k)
- Regulation Number
- 862.3280 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-Level by More Diagnostics Inc — Class I — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED
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 | K072257 | Class I | Active |
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Manufacturer
- Manufacturer
- More Diagnostics Inc
- FDA Applicant
- More Diagnostics
Sources (2)
- FDA 510(k) K072257 24 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 19, 2026