LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators— 510(k) K142895
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K142895 for LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators, Substantially Equivalent on 2015-05-21. Applicant: Fujirebio Diagnostics,Inc..
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code LTK
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.