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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 K050780
Device Name BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML
Applicant
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152
Applicant Contact LINDA DILLON
Correspondent
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152
Correspondent Contact LINDA DILLON
Regulation Number866.1645
Classification Product Code
LON  
Date Received03/28/2005
Decision Date 05/12/2005
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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