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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 K113783
Device Name VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Applicant Contact ELIZABETH LANDON
Correspondent
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Correspondent Contact ELIZABETH LANDON
Regulation Number866.1645
Classification Product Code
LON  
Date Received12/22/2011
Decision Date 08/07/2012
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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