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FDA 510(k) Application Details - K141827
Device Classification Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K141827
Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
EUROIMMUN U.S., Inc.
1100 THE AMERICAN ROAD
MORRIS PLAINS, NJ 07950 US
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Contact
MICHAEL A LOCKE
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Regulation Number
866.5100
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Classification Product Code
DHN
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More FDA Info for this Product Code
Date Received
07/07/2014
Decision Date
04/17/2015
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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