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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name manual antimicrobial susceptibility test systems
510(k) Number K121002
Device Name ETEST CEFTAROLINE
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood,  MO  63042
Original Contact jennifer chia-hsuan lin
Regulation Number866.1640
Classification Product Code
JWY  
Date Received04/02/2012
Decision Date 10/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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