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FDA 510(k) Application Details - DEN070004
Device Classification Name
Assay, Enterovirus Nucleic Acid
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510(K) Number
DEN070004
Device Name
Assay, Enterovirus Nucleic Acid
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089-1189 US
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Contact
RUSSEL K ENNS, PH.D.
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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
03/12/2007
Decision Date
03/16/2007
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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