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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name culture media, selective and differential
510(k) Number K832955
Device Name BACTEROIDES BILE ESCULIN AGAR
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Regulation Number866.2360
Classification Product Code
JSI  
Date Received08/31/1983
Decision Date 09/29/1983
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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