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FDA 510(k) Application Details - K103684
Device Classification Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
More FDA Info for this Device
510(K) Number
K103684
Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant
BIO-RAD
180 Cabot Street
Beverly, MA 01915 US
Other 510(k) Applications for this Company
Contact
FRAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
866.1700
More FDA Info for this Regulation Number
Classification Product Code
JSO
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More FDA Info for this Product Code
Date Received
12/17/2010
Decision Date
10/21/2011
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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