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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunochemical, transferrin
Regulation Description Transferrin immunological test system.
Product CodeJNM
Regulation Number 866.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
Nichols Institute Diagnostics
  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 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 R & D Systems, Inc. II Sep-26-2016

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