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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 K102668
Device Name ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
Applicant
BIOMERIEUX
5 Rue Des Aqueducs
Craponne,  FR 69290
Applicant Contact ASA KARLSSON
Correspondent
BIOMERIEUX
5 Rue Des Aqueducs
Craponne,  FR 69290
Correspondent Contact ASA KARLSSON
Regulation Number866.1640
Classification Product Code
JWY  
Date Received09/16/2010
Decision Date 11/17/2010
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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