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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, collection, capillary blood
Regulation Description Capillary blood collection tube.
Product CodeGIO
Regulation Number 864.6150
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 2
Other (for use when an appropriate device code cannot be identified) 2
Material integrity issue 1
Total Device Problems 5

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