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510(k) K013432

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G by Immuno Concepts, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2001
Date Received
October 15, 2001
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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