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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 K922475
Device Name BACTEC 9120 SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.2560
Classification Product Code
MDB  
Date Received05/26/1992
Decision Date 07/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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