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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nad-nadh, specific reagent for alcohol enzyme method
Regulation Description Alcohol test system.
Product CodeDML
Regulation Number 862.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 1
Total Device Problems 1

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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