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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 K023075
FOIA Releasable 510(k) K023075
Device Name BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
Applicant
Bd Vacutainer Systems Preanalyical Solutions
1 Becton Dr., Mcc 300
Franklin Lakes,  NJ  07417
Applicant Contact JING ZHANG
Correspondent
Bd Vacutainer Systems Preanalyical Solutions
1 Becton Dr., Mcc 300
Franklin Lakes,  NJ  07417
Correspondent Contact JING ZHANG
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/16/2002
Decision Date 11/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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