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FDA 510(k) Application Details - K151923
Device Classification Name
Susceptibility Test Plate, Antifungal
More FDA Info for this Device
510(K) Number
K151923
Device Name
Susceptibility Test Plate, Antifungal
Applicant
BIOMERIEUX, INC.
595 Anglum Road
Hazelwood, MO 63042 US
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Contact
Cherece L Jones
Other 510(k) Applications for this Contact
Regulation Number
866.1640
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Classification Product Code
NGZ
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More FDA Info for this Product Code
Date Received
07/13/2015
Decision Date
03/25/2016
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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