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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator for hemoglobin and hematocrit measurement
Regulation Description Calibrator for hemoglobin or hematocrit measurement.
Product CodeKRZ
Regulation Number 864.8165
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 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 0 0 0
Class III 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. III Jan-11-2012

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