Name: Predicase
Price: 199 USD

K-number	K142895
Device name	LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
Applicant	Fujirebio Diagnostics,Inc.
Product code	LTK
Device class	Class II
Decision date	May 21, 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 G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

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