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FDA 510(k) Application Details - K083381
Device Classification Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
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510(K) Number
K083381
Device Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Applicant
EUROIMMUN US INC
95 WASHINGTON ST
MORRISTOWN, NJ 07960 US
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Contact
KATHRYN KOHL
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Regulation Number
866.5100
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Classification Product Code
LRM
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More FDA Info for this Product Code
Date Received
11/14/2008
Decision Date
04/15/2009
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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