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510(k) K203599

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System by Immuno Concepts, N.A. , Ltd. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2023
Date Received
December 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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