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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, c-reactive protein
Regulation Description C-reactive protein immunological test system.
Product CodeDCN
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 4
Low test results 3
False positive result 1
Incorrect or inadequate test results 1
Total Device Problems 9

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. III Sep-08-2009

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