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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 K921133
Device Name BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.2560
Classification Product Code
MDB  
Date Received03/10/1992
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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