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FDA 510(k) Application Details - K190405
Device Classification Name
System, Blood Culturing
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510(K) Number
K190405
Device Name
System, Blood Culturing
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazelwood, MO 63042 US
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Contact
Esther Hernandez
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Regulation Number
866.2560
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Classification Product Code
MDB
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More FDA Info for this Product Code
Date Received
02/19/2019
Decision Date
05/15/2019
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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