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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device activated partial thromboplastin
Regulation Description Partial thromboplastin time tests.
Product CodeGFO
Regulation Number 864.7925
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 5
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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