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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion based, enzymatic, creatinine
Regulation Description Creatinine test system.
Product CodeCGL
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point of Care Inc. II Nov-24-2010
2 Nova Biomedical Corporation II May-07-2009
3 Nova Biomedical Corporation II Feb-16-2008
4 Radiometer America Inc II Feb-13-2012
5 Radiometer America Inc II Mar-05-2010

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