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

Name: FDA 510(k) clearance K153145
Creator: U.S. Food and Drug Administration
Published: 2016-07-05

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.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2015-10-30
Decision date: 2016-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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