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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, fibrinogen determination
Regulation Description Fibrinogen determination system.
Product CodeKQJ
Regulation Number 864.7340
Device Class 2


Premarket Reviews
ManufacturerDecision
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fisher Diagnostics II Jul-25-2017

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