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FDA 510(k) Application Details - K133817
Device Classification Name
Susceptibility Test Plate, Antifungal
More FDA Info for this Device
510(K) Number
K133817
Device Name
Susceptibility Test Plate, Antifungal
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM, NC 27712 US
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Contact
JOCELYN JENNINGS
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
NGZ
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More FDA Info for this Product Code
Date Received
12/16/2013
Decision Date
08/05/2014
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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