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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nephelometer, for clinical use
Regulation Description Nephelometer for clinical use.
Product CodeJQX
Regulation Number 862.2700
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2

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 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-10-2010

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