Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators— 510(k) K151378
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K151378 for Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators, Substantially Equivalent on 2015-11-24. Applicant: Fujirebio Diagnostics,Inc..
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code OIU
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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