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FDA 510(k) Application Details - K082534
Device Classification Name
Susceptibility Test Plate, Antifungal
More FDA Info for this Device
510(K) Number
K082534
Device Name
Susceptibility Test Plate, Antifungal
Applicant
AB BIOMERIEUX
DALVAGEN 10
SOLNA 16956 SE
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Contact
ANETTE ENGELHARDT
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
NGZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/02/2008
Decision Date
11/02/2009
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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