Lumipulse G Progesterone-N Calibrators— 510(k) K163546
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K163546 for Lumipulse G Progesterone-N Calibrators, Substantially Equivalent on 2017-01-13. Applicant: Fujirebio Diagnostics,Inc..
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code JIT
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Malvern, PA, US
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