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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, urine leukocyte
Regulation Description Leukocyte peroxidase test.
Product CodeLJX
Regulation Number 864.7675
Device Class 1


Premarket Reviews
ManufacturerDecision
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 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 0
Class III 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ARKRAY USA INC. III Sep-30-2010

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