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FDA 510(k) Application Details - K120466
Device Classification Name
Drug Metabolizing Enzyme Genotyping Systems
More FDA Info for this Device
510(K) Number
K120466
Device Name
Drug Metabolizing Enzyme Genotyping Systems
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK, IL 60062 US
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Contact
MARK DEL VECCHIO
Other 510(k) Applications for this Contact
Regulation Number
862.3360
More FDA Info for this Regulation Number
Classification Product Code
NTI
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More FDA Info for this Product Code
Date Received
02/15/2012
Decision Date
11/06/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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