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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, human growth hormone
Regulation Description Human growth hormone test system.
Product CodeCFL
Regulation Number 862.1370
Device Class 1


Premarket Reviews
ManufacturerDecision
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 1
No Known Device Problem 1
Total Device Problems 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 0 0 1 1 0 0 0 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 May-11-2011
2 Beckman Coulter Inc. II Sep-28-2010

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