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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, immunoreactive insulin
Regulation Description Immunoreactive insulin test system.
Product CodeCFP
Regulation Number 862.1405
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 2
Low test results 2
No Known Device Problem 1
Total Device Problems 5

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 1 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 Jun-25-2008
2 Siemens Healthcare Diagnostics II Jun-02-2012

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