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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name culture media, antimicrobial susceptibility test, excluding mueller hinton agar
510(K) Number K122187
Device Name VRESELECT CULTURE MEDIUM
Applicant
BIO-RAD
180 cabot street
beverly,  MA  01915
Contact fran white
Regulation Number866.1700
Classification Product Code
JSO  
Date Received07/24/2012
Decision Date 11/06/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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