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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 K101502
Device Name BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
Applicant
BECTON DICKINSON & CO.
1 BECTON DRIVE, MC300
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact MARY ANNE ALSBERGE
Correspondent
BECTON DICKINSON & CO.
1 BECTON DRIVE, MC300
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact MARY ANNE ALSBERGE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/01/2010
Decision Date 06/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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