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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calibrators, drug specific
Regulation Description Clinical toxicology calibrator.
Product CodeDLJ
Regulation Number 862.3200
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 8
EMD
  SUBSTANTIALLY EQUIVALENT 1
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Dec-16-2010
2 Lin-Zhi International Inc II Mar-12-2014
3 Microgenics Corp II Jan-17-2012
4 Microgenics Corp II Nov-28-2011

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