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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, non-propagating transport
510(k) Number K024240
Device Name BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
Applicant
BD
1 BECTON DR.
MC 300
FRANKLIN LAKES,  NJ  07417
Applicant Contact JING ZHANG
Correspondent
BD
1 BECTON DR.
MC 300
FRANKLIN LAKES,  NJ  07417
Correspondent Contact JING ZHANG
Regulation Number866.2390
Classification Product Code
JSM  
Date Received12/23/2002
Decision Date 03/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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