510(k) K172713— Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set

Substantially Equivalent

Fujirebio Diagnostics,Inc.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code PRI
Advisory panel: Microbiology
Date received: 2017-09-08
Decision date: 2017-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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