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FDA 510(k) Application Details - K131185
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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510(K) Number
K131185
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
EUROIMMUN US
1100 THE AMERICAN ROAD
MORRIS PLAINS, NJ 07950 US
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Contact
MICHAEL LOCKE
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Regulation Number
866.5100
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Classification Product Code
LJM
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More FDA Info for this Product Code
Date Received
04/26/2013
Decision Date
07/15/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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