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Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
FDA 510(k)Class II (US FDA 510(k))
510(k) K151378
Identifiers
- 510(k) Number
- K151378 FDA 510(k)
- FDA Product Code
- OIU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6010 FDA 510(k)
- Regulation Number
- 866.6010 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators by Fujirebio Diagnostics, Inc. — Class II — FDA_510K — listed in FDA 510(k)
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 | K151378 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
- FDA Applicant
- Fujirebio Diagnostics,Inc.
Sources (1)
- FDA 510(k) K151378 24 fields · synced Jun 18, 2026