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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 K093972
Device Name BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
Applicant
BECTON DICKINSON & CO.
1 BECTON DRIVE, MC 300
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact JULIE T WING
Correspondent
BECTON DICKINSON & CO.
1 BECTON DRIVE, MC 300
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact JULIE T WING
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/24/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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