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FDA 510(k) Application Details - K063261
Device Classification Name
Assay, Enterovirus Nucleic Acid
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510(K) Number
K063261
Device Name
Assay, Enterovirus Nucleic Acid
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM, NC 27712 US
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Contact
SANDRA PERREAND
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Regulation Number
866.3225
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Classification Product Code
OAI
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More FDA Info for this Product Code
Date Received
10/30/2006
Decision Date
06/23/2008
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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