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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hydrazone colorimetry, alt/sgpt
Regulation Description Alanine amino transferase (ALT/SGPT) test system.
Product CodeCKD
Regulation Number 862.1030
Device Class 1


Premarket Reviews
ManufacturerDecision
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CHOLESTECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 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 0 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Apr-17-2013

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