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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Neisseria
510(k) Number K052481
Device Name BD VIPER SYSTEM
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact COLLEEN A KISTLER
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact COLLEEN A KISTLER
Regulation Number866.3390
Classification Product Code
LSL  
Date Received09/09/2005
Decision Date 11/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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