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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, selective and non-differential
Regulation Description Selective culture medium.
Product CodeJSJ
Regulation Number 866.2360
Device Class 1


Premarket Reviews
ManufacturerDecision
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 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jul-24-2013
2 Hardy Diagnostics II Apr-26-2016

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