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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, systemic lupus erythematosus
Regulation Description Systemic lupus erythematosus immunological test system.
Product CodeDHC
Regulation Number 866.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2

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 Bio-Rad Laboratories Inc III Mar-16-2010

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