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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ph rate measurement, carbon-dioxide
Regulation Description Bicarbonate/carbon dioxide test system.
Product CodeJFL
Regulation Number 862.1160
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
NOVA
  SUBSTANTIALLY EQUIVALENT 2

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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