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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device method, nephelometric, immunoglobulins (g, a, m)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Product CodeCFN
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 6
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

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 1 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corp. II Jan-17-2007
2 Siemens Healthcare Diagnostics, Inc. III Mar-17-2015

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