K-number	K153117
Device name	AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
Applicant	Aesku Systems GmbH&Co.Kg
Product code	DHN
Device class	Class II
Decision date	Jul 28, 2016
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

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