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FDA 510(k) Application Details - K203599
Device Classification Name
Anti-Dna Indirect Immunofluorescent Solid Phase
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510(K) Number
K203599
Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Applicant
Immuno Concepts N.A., Ltd.
9825 Goethe Road, Suite #350
Sacramento, CA 95827 US
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Contact
Eric S. Hoy
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Regulation Number
866.5100
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Classification Product Code
KTL
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More FDA Info for this Product Code
Date Received
12/09/2020
Decision Date
05/26/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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