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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, hemoglobin, automated
Regulation Description Automated hemoglobin system.
Product CodeGKR
Regulation Number 864.5620
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Measurements, inaccurate 2
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 2 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hemo Cue, Inc. II Mar-30-2011
2 ITC-Nexus Dx, Inc. II Mar-31-2011

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