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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 K002456
Device Name MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
Applicant
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lakes,  NJ  07417 -1885
Applicant Contact James Haynes
Correspondent
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lakes,  NJ  07417 -1885
Correspondent Contact James Haynes
Regulation Number862.1675
Classification Product Code
JKA  
Date Received08/10/2000
Decision Date 11/02/2000
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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