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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, enzyme, for clinical use
Regulation Description Enzyme analyzer for clinical use.
Product CodeJJI
Regulation Number 862.2500
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  1.  K931970  ABBOTT IMX2 ANALYER
  2.  K944731  ABBOTT IMX 2 ANALYZER
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Computer software issue 1
Incorrect software programming calculations 1
Programming issue 1
Total Device Problems 3

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 0 0 0 0 0 0 0 0 0
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories MPG III Mar-08-2007

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