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FDA 510(k) Application Details - K081212
Device Classification Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
More FDA Info for this Device
510(K) Number
K081212
Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant
BIO-RAD
163 CABOT ST.
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
Other 510(k) Applications for this Contact
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
04/29/2008
Decision Date
06/13/2008
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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