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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, bleeding time
Regulation Description Bleeding time device.
Product CodeJCA
Regulation Number 864.6100
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 4
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 2
Total Device Problems 2

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 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ITC-Nexus Dx II Jun-26-2015

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