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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 K940905
Device Name MICROTAINER BRAND TUBE WITH EDTA(K2)
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact RUSSELL J ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact RUSSELL J ARNSBERGER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/24/1994
Decision Date 08/02/1994
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
Recalls CDRH Recalls
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