Name: Predicase
Price: 199 USD

K-number	K153361
Device name	Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
Applicant	Fujirebio Diagnostics,Inc.
Product code	MRG
Device class	Class II
Decision date	Apr 15, 2016
Decision	Substantially Equivalent
Regulation	862.1825

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Source

View the full FDA submission: accessdata.fda.gov

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Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

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