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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
Recalls CDRH Recalls
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