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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, test, thyroid autoantibody
Regulation Description Thyroid autoantibody immunological test system.
Product CodeJZO
Regulation Number 866.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
FISHER
  SUBSTANTIALLY EQUIVALENT 2
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 2
PHARMACIA & UPJOHN CO.
  SUBSTANTIALLY EQUIVALENT 4
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
High test results 6
Total Device Problems 6

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 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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