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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, test, anticardiolipin immunological
Regulation Description Multiple autoantibodies immunological test system.
Product CodeMID
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY
  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 2 0 0 1 0 0 0 0 0 0
Class III 1 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Calbiotech Inc II Mar-05-2010
2 Louisville Apl Diagnostics Inc III Oct-04-2007
3 Louisville Apl Diagnostics Inc II Aug-17-2007
4 Louisville Apl Diagnostics Inc II Jul-24-2007
5 Phadia US Inc III Aug-28-2012

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