Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set— 510(k) K172713
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K172713 for Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set, Substantially Equivalent on 2017-12-10. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code PRI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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More clearances from Fujirebio Diagnostics,Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.