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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, blood culturing
510(k) Number K915796
Device Name BACTEC 9240 SYSTEM
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
33 MANSELL COURT
P.O. BOX 337
ROSWELL,  GA  30077
Applicant Contact FRANK J SWENSON
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
33 MANSELL COURT
P.O. BOX 337
ROSWELL,  GA  30077
Correspondent Contact FRANK J SWENSON
Regulation Number866.2560
Classification Product Code
MDB  
Date Received12/24/1991
Decision Date 04/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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