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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, coagulation
Regulation Description Coagulation instrument.
Product CodeKQG
Regulation Number 864.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate test results 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 International Technidyne Corp. II Feb-11-2011

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