K-number	K190702
Device name	Lumipulse G whole PTH
Applicant	Fujirebio Diagnostics,Inc.
Product code	CEW
Device class	Class II
Decision date	Aug 30, 2019
Decision	Substantially Equivalent
Regulation	862.1545

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Source

View the full FDA submission: accessdata.fda.gov

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Lumipulse G whole PTH

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