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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, progesterone
Regulation Description Progesterone test system.
Product CodeJLS
Regulation Number 862.1620
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 3
Low test results 2
High test results 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Sep-29-2010
2 Siemens Healthcare Diagnostics, Inc II Mar-02-2015
3 Siemens Medical Solutions Diagnostics II Dec-23-2008

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