Name: Predicase
Price: 199 USD

K-number	K162961
Device name	LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
Applicant	DiaSorin, Inc.
Product code	LSE
Device class	Class I
Decision date	Jan 5, 2017
Decision	Substantially Equivalent
Regulation	866.3235

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

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