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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nadh oxidation/nad reduction, alt/sgpt
Regulation Description Alanine amino transferase (ALT/SGPT) test system.
Product CodeCKA
Regulation Number 862.1030
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 5
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Low test results 2
High test results 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Abaxis, Incorporated II Feb-09-2011
2 Alfa Wassermann, Inc. II Apr-30-2014
3 Pointe Scientific, Inc. II May-22-2008

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