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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K041071
Device Name BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
Applicant
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact JING ZHANG
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact JING ZHANG
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/26/2004
Decision Date 05/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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