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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device c-reactive protein, antigen, antiserum, and control
Regulation Description C-reactive protein immunological test system.
Product CodeDCK
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
CHOLESTECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
FISHER
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  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 1 0 0 1
Class III 0 1 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Apr-25-2013
2 Beckman Coulter Inc III Mar-02-2010
3 Cholestech Corp III Sep-20-2008
4 Kamiya Biomedical Company, LLC II Mar-04-2010

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