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FDA 510(k) Application Details - K123418
Device Classification Name
Kit, Identification, Enterobacteriaceae
More FDA Info for this Device
510(K) Number
K123418
Device Name
Kit, Identification, Enterobacteriaceae
Applicant
ADVANDX, INC.
400 TradeCenter Suite 6990
WOBURN, MA 01801 US
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Contact
BENJAMIN S CRYSTAL
Other 510(k) Applications for this Contact
Regulation Number
866.2660
More FDA Info for this Regulation Number
Classification Product Code
JSS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2012
Decision Date
07/21/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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