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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K023955
Device Name BD VIPER INSTRUMENT
Applicant
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Applicant Contact COLLEN A KISTLER
Correspondent
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact COLLEN A KISTLER
Regulation Number862.2750
Classification Product Code
JQW  
Date Received11/27/2002
Decision Date 06/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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