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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, general purpose, microbiology, diagnostic
Regulation Description Microorganism differentiation and identification device.
Product CodeLIB
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 4
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 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 4 0 1
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Feb-04-2016
2 BioMerieux SA II Apr-18-2014
3 Biomerieux Inc II Mar-12-2014
4 Remel Inc II Dec-16-2014
5 Remel Inc II Apr-18-2014
6 Remel Inc III May-14-2008

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