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FDA 510(k) Application Details - K162076
Device Classification Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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510(K) Number
K162076
Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazelwood, MO 63042 US
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Contact
Karen Russell
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Regulation Number
866.1700
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Classification Product Code
JSO
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More FDA Info for this Product Code
Date Received
07/27/2016
Decision Date
10/25/2016
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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