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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device alpha-1-lipoprotein, antigen, antiserum, control
Regulation Description Alpha-1-lipoprotein immunological test system.
Product CodeDER
Regulation Number 866.5580
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 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 0 0 0 0 0 0 0 0 0 0


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