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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
Other (for use when an appropriate device code cannot be identified) 2
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 2 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Drummond Scientific Co II Nov-07-2008
2 Opti Medical Systems Inc II Aug-14-2008
3 Radiometer America Inc II Jul-03-2007

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