Name: Predicase
Price: 199 USD

K-number	K192046
Device name	LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
Applicant	DiaSorin, Inc.
Product code	QFO
Device class	Class II
Decision date	Oct 28, 2019
Decision	Substantially Equivalent
Regulation	866.3935

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Source

View the full FDA submission: accessdata.fda.gov

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LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

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