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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 K063492
Device Name VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact JOHN TENLLADO
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact JOHN TENLLADO
Regulation Number866.1645
Classification Product Code
LON  
Date Received11/17/2006
Decision Date 12/21/2006
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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