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Liason Xl1, 25 Dihydroxyvitamin D +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K141463
Identifiers
- 510(k) Number
- K141463 FDA 510(k)
- FDA Product Code
- MRG FDA 510(k)
- Models / Variants
- Liason Xl1, 25 Dihydroxyvitamin D FDA 510(k)Control Set, Calibration Verifiers FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1825 FDA 510(k)
- Regulation Number
- 862.1825 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Liason Xl1, 25 Dihydroxyvitamin D +1 more model by Diasorin Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — 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 | K141463 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K141463 24 fields · synced Jun 19, 2026