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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, automated, antimicrobial susceptibility, short incubation
510(k) Number K032314
Device Name VITEK 2 GRAM POSITIVE GATIFLOXACIN
Applicant
BIOMERIEUX, INC.
595 ANGLUM DR.
HAZELWOOD,  MO  63042 -2320
Applicant Contact Nancy Weaver
Correspondent
BIOMERIEUX, INC.
595 ANGLUM DR.
HAZELWOOD,  MO  63042 -2320
Correspondent Contact Nancy Weaver
Regulation Number866.1645
Classification Product Code
LON  
Date Received07/28/2003
Decision Date 08/22/2003
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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