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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alkaline picrate, colorimetry, creatinine
Regulation Description Creatinine test system.
Product CodeCGX
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 7
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 4
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 33
High test results 12
Low test results 6
Total Device Problems 51

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Mar-15-2013
2 Beckman Coulter Inc. II Sep-09-2010
3 Horiba Instruments, Inc dba Horiba Medical III Nov-14-2012
4 Pointe Scientific, Inc. II Mar-09-2010
5 Roche Diagnostics Corp. II Oct-09-2008
6 Siemens Healthcare Diagnostics, Inc. II Jan-15-2012

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