K-number	K163053
Device name	Lumipulse G E2-III Calibrators
Applicant	Fujirebio Diagnostics,Inc.
Product code	JIT
Device class	Class II
Decision date	Dec 1, 2016
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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Lumipulse G E2-III Calibrators

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