K-number	K153145
Device name	Lumipulse G TP-N Immunoreaction Cartridge Set
Applicant	Fujirebio Diagnostics,Inc.
Product code	LIP
Device class	Class II
Decision date	Jul 5, 2016
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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Lumipulse G TP-N Immunoreaction Cartridge Set

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