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FDA 510(k) Application Details - K083464
Device Classification Name
Campylobacter Spp.
More FDA Info for this Device
510(K) Number
K083464
Device Name
Campylobacter Spp.
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
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Contact
SUSAN D ROLIH
Other 510(k) Applications for this Contact
Regulation Number
866.3110
More FDA Info for this Regulation Number
Classification Product Code
LQP
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More FDA Info for this Product Code
Date Received
11/24/2008
Decision Date
01/30/2009
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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