K-number	K161964
Device name	ADVIA Centaur HAV IgM Assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	LOL
Device class	Class II
Decision date	Oct 13, 2016
Decision	Substantially Equivalent
Regulation	866.3310

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur HAV IgM Assay

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