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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device susceptibility test discs, antimicrobial
Regulation Description Antimicrobial susceptibility test disc.
Product CodeJTN
Regulation Number 866.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 21
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 8
UNIPATH
  SUBSTANTIALLY EQUIVALENT 10
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 4

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 1 0 0 0 0 0 2 3 1 0
Class III 0 0 0 0 0 0 2 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Mar-29-2007
2 Remel Inc II Dec-17-2015
3 Remel Inc II Mar-20-2014
4 Remel Inc II Jan-21-2014
5 Remel Inc II Jan-14-2014
6 Remel Inc III Dec-17-2013
7 Remel Inc III Aug-26-2013
8 Remel Inc II Feb-12-2013
9 Remel Inc II Feb-06-2013

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