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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, cortisol
Regulation Description Cortisol (hydrocortisone and hydroxycorticosterone) test system.
Product CodeCGR
Regulation Number 862.1205
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 3
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate test results 1
Total Device Problems 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 0 0 0 1 1 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jul-08-2011
2 Beckman Coulter Inc. II Sep-29-2010
3 Siemens Healthcare Diagnostics II Oct-23-2014

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