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FDA 510(k) Application Details - K031952
Device Classification Name
Elisa, Antibody, West Nile Virus
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510(K) Number
K031952
Device Name
Elisa, Antibody, West Nile Virus
Applicant
FOCUS TECHNOLOGIES, INC.
10703 PROGRESS WAY
CYPRESS, CA 90630-4737 US
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Contact
MICHAEL J WAGNER
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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
06/25/2003
Decision Date
10/22/2003
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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