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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, transport, aerobic
510(k) Number K790366
Device Name URINE CULTURE KIT
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 Number866.2900
Classification Product Code
JTW  
Date Received02/22/1979
Decision Date 04/04/1979
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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