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FDA 510(k) Application Details - K091025
Device Classification Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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510(K) Number
K091025
Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD, MO 63042 US
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Contact
Nancy Weaver
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Regulation Number
866.1700
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Classification Product Code
JSO
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Date Received
04/10/2009
Decision Date
03/02/2010
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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