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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ferrozine (colorimetric) iron binding capacity
Regulation Description Iron-binding capacity test system.
Product CodeJMO
Regulation Number 862.1415
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 2

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 1 1 0 0 1 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostic Chemicals, Ltd. III May-13-2009
2 Ortho-Clinical Diagnostics III Jul-01-2016
3 Siemens Healthcare Diagnostics, Inc. III Mar-11-2013
4 Siemens Healthcare Diagnostics, Inc. III Sep-08-2010

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