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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, hematocrit, automated
Regulation Description Automated hematocrit instrument.
Product CodeGKF
Regulation Number 864.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVA
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

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


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