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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nad reduction/nadh oxidation, lactate dehydrogenase
Regulation Description Lactate dehydrogenase test system.
Product CodeCFJ
Regulation Number 862.1440
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  1.  K841703  TDX REA LDH
  2.  K881474  VISION(R) LDH (LACTATE DEHYDROGENASE)
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False negative result 1
Device ingredient or reagent issue 1
Total Device Problems 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 1 0 1 1
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 Roche Diagnostics Operations, Inc. II Jun-27-2015
3 Siemens Healthcare Diagnostics, Inc. II May-11-2016

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