Lumipulse G TP-N Immunoreaction Cartridge Set— 510(k) K153145

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K153145 for Lumipulse G TP-N Immunoreaction Cartridge Set, Substantially Equivalent on 2016-07-05. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code LIP
Advisory panel: Microbiology
Date received: 2015-10-30
Decision date: 2016-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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