Name: Predicase
Price: 199 USD

K-number	K181213
Device name	ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	LFZ
Device class	Class II
Decision date	Jul 30, 2018
Decision	Substantially Equivalent
Regulation	866.3175

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

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