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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hemoglobin a1c test system
Regulation Description Hemoglobin A1c test system.
Definition Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Product CodePDJ
Regulation Number 862.1373
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 1
Patient Data Issue 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Nov-11-2016

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