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510(k) K160265

Image Navigator by Immuno Concepts by Immuno Concepts, N.A. , Ltd. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2016
Date Received
February 2, 2016
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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