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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device counter (beta, gamma) for clinical use
Regulation Description Beta or gamma counter for clinical use.
Product CodeJJJ
Regulation Number 862.2320
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
  1.  K761214  WELL COUNTERS, LOGIC II (200 SERIES)
  2.  K771129  AUTO-LOGIC II SYSTEM
  3.  K790905  NUCLEAR SAMPLE READER
  4.  K920559  ABBOTT VERTEX ANALYZER
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Pressure issue 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 0 0 0 0 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Perkinelmer II Jan-12-2016
2 Perkinelmer II Jul-20-2015

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