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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, low density, lipoprotein
Regulation Description Lipoprotein test system.
Product CodeMRR
Regulation Number 862.1475
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Polymer Technology Systems, Inc. III Mar-15-2010
2 Roche Diagnostics Corp. II Oct-09-2008
3 Roche Diagnostics Operations, Inc. II Jun-27-2015
4 Siemens Healthcare Diagnostics, Inc. II May-11-2016

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