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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ion-specific, chloride
Regulation Description Chloride test system.
Product CodeCGZ
Regulation Number 862.1170
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
OSMETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SENDX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WESCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer hardware error 2
Malfunction 1
Miscalibration 1
High test results 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 1 0 0 0 0 0
Class III 0 1 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Sep-11-2008
2 Abbott Laboratories, Inc III May-24-2008
3 OPTI Medical Systems, Inc II Jun-14-2011
4 OPTI Medical Systems, Inc III Mar-11-2010

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