Name: Predicase
Price: 199 USD

K-number	K151378
Device name	Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
Applicant	Fujirebio Diagnostics,Inc.
Product code	OIU
Device class	Class II
Decision date	Nov 24, 2015
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 HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

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