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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, non-selective and non-differential
Regulation Description Multipurpose culture medium.
Product CodeJSG
Regulation Number 866.2300
Device Class 1


Premarket Reviews
ManufacturerDecision
DOW
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  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 1 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jan-14-2015
2 Becton Dickinson & Co. II May-16-2013
3 Remel Inc II Jun-10-2015

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