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FDA 510(k) Application Details - K092957
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K092957
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK, IL 60062 US
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Contact
GREGORY SHIPP
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Regulation Number
866.3980
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Classification Product Code
OCC
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More FDA Info for this Product Code
Date Received
09/25/2009
Decision Date
10/21/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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