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FDA 510(k) Application Details - K052519
Device Classification Name
Elisa, Antibody, West Nile Virus
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510(K) Number
K052519
Device Name
Elisa, Antibody, West Nile Virus
Applicant
SPECTRAL DIAGNOSTICS, INC.
135-2 THE WEST MALL
TORONTO, ONTARIO M9C 1C2 CA
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Contact
NISAR A SHAIKH
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Regulation Number
866.3940
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Classification Product Code
NOP
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Date Received
09/14/2005
Decision Date
11/30/2006
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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