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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 K953994
Device Name SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
Applicant
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact DENISE DUCHENE
Correspondent
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact DENISE DUCHENE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received08/24/1995
Decision Date 09/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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