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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, digitoxin
Regulation Description Digitoxin test system.
Product CodeLFM
Regulation Number 862.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAYER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Aug-15-2012
2 Siemens Healthcare Diagnostics, Inc II Dec-11-2012

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