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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nitrophenylphosphate, alkaline phosphatase or isoenzymes
Regulation Description Alkaline phosphatase or isoenzymes test system.
Product CodeCJE
Regulation Number 862.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Sep-26-2011
2 Ortho-Clinical Diagnostics II Nov-15-2013
3 Pointe Scientific, Inc. II Mar-27-2008

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