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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device photometric method, iron (non-heme)
Regulation Description Iron (non-heme) test system.
Product CodeJIY
Regulation Number 862.1410
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
  1.  K972363  IL TEST IRON

Device Problems
Low test results 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Nov-15-2013
2 Pointe Scientific, Inc. II Mar-02-2010
3 Roche Diagnostics Corp. II Oct-09-2008
4 Siemens Healthcare Diagnostics, Inc. II Dec-03-2012

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