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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubes, vacuum sample, with anticoagulant
Regulation Description Blood specimen collection device.
Product CodeGIM
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
THE UNIVERSITY OF CHICAGO
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 1
Shielding failure 1
Total Device Problems 2

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