K-number	K192524
Device name	Lumipulse G CA15-3
Applicant	Fujirebio Diagnostics,Inc.
Product code	MOI
Device class	Class II
Decision date	Sep 4, 2020
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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Lumipulse G CA15-3

Everything you need for a 510(k) submission. Nothing you don't.