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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluorometer, for clinical use
Regulation Description Fluorometer for clinical use.
Product CodeKHO
Regulation Number 862.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 11
Low test results 1
False negative result 1
Total Device Problems 13

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 0 0 2 1 0 1 0
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Jan-27-2012
2 PerkinElmer Life and Analytical Sciences, Wallac, OY II Feb-28-2012
3 Tecan US, Inc. II Jul-02-2015
4 Tecan US, Inc. III Jan-15-2015
5 Tosoh Smd Inc II Jul-30-2013

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