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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, occult blood
Regulation Description Occult blood test.
Product CodeKHE
Regulation Number 864.6550
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 2
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 8
False negative result 6
Smoking 1
Low test results 1
Total Device Problems 16

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 0 1 0 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alere North Americal II Apr-28-2011
2 Enterix, Inc. II Dec-29-2008
3 Polymedco, Inc II Apr-04-2013

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