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510(k) K153117

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM by Aesku Systems GmbH&Co.Kg — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2016
Date Received
October 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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