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FDA 510(k) Application Details - K153308
Device Classification Name
Elisa, Antibody, West Nile Virus
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510(K) Number
K153308
Device Name
Elisa, Antibody, West Nile Virus
Applicant
EUROIMMUN US, INC.
1100 THE AMERICAN ROAD
MORRIS PLAINS, NJ 07950 US
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Contact
Michael Locke
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Regulation Number
866.3940
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Classification Product Code
NOP
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More FDA Info for this Product Code
Date Received
11/17/2015
Decision Date
08/12/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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